FDA product code · Clinical Chemistry
NBWSystem, Test, Blood Glucose, Over The Counter
Product code NBW covers System, Test, Blood Glucose, Over The Counter, a Class II device regulated under 21 CFR 862.1345. FDA has cleared 509 devices in this code, 2 of them in the last 12 months. Median review time across the 509 most recent decisions is 153 days. openFDA lists 137 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 862.1345
- Review panel
- Clinical Chemistry
- Clearances
- 509
What is happening in NBW right now?
NBW (System, Test, Blood Glucose, Over The Counter) has two findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class I, Class II) (Z-1545-2026, Z-1546-2026, Z-1547-2026, Z-1548-2026, Z-0413-2026). The code is crowded, scoring 62 of 100 — 113 companies hold a clearance here and 2 arrived in the last 12 months (NBW:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class I recall | Z-1545-2026, Z-1546-2026, Z-1547-2026, Z-1548-2026, Z-0413-2026 |
| Crowding | Context | NBW:crowding |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
How many devices has FDA cleared in NBW?
FDA has cleared 509 devices under product code NBW since the 510(k) programme began in 1976, 2 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262116 | TRUE METRIX Self Monitoring Blood Glucose System | Trividia Health, Inc. | |
| K250085 | On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring System | ACON Laboratories, Inc. | |
| K243060 | TeleRPM Gen2 Blood Glucose Monitoring System | Guangdong Transtek Medical Electronics Co., Ltd. | |
| K240637 | RIGHTEST Blood Glucose Monitoring System Max Tel | Bionime Corporation | |
| K240640 | Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring System | Sejoy Biomedical Co., Ltd. | |
| K241787 | CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System | Ascensia Diabetes Care U.S., Inc. | |
| K222126 | VivaChek Fad Blood Glucose Monitoring System, VivaChek Fad Smart Blood Glucose Monitoring System, VivaChek Fad Sync Blood Glucose Monitoring System | Vivachek Biotech (Hangzhou) Co., Ltd. | |
| K241304 | WaveSense Jazz Blood Glucose Monitoring System | Agamatrix | |
| K231679 | CONTOUR® PLUS BLUE Blood Glucose Monitoring System | Ascensia Diabetes Care | |
| K231192 | RIGHTEST Blood Glucose Monitoring System Max Tel | Bionime Corporation |
How long does FDA review take for NBW?
The median FDA review time for NBW is 153 days, measured across the 509 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in NBW?
openFDA lists 137 recall records against product code NBW. A recall record covers one firm's corrective action and may span many device lots.
Z-1545-2026Open, ClassifiedTrividia Health, Inc.
The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended actions for the E-5 error code in the labeling do not: (a) clearly emphasize that an E-5 error code could represent a very high blood glucose level, and (b) prominently convey the appropriate immediate actions, such as contacting a healthcare professional. This could lead to a delay in treatment if the user does not seek medical attention immediately when receiving an E-5 error code and experiencing symptoms of high glucose.
Z-1546-2026Open, ClassifiedTrividia Health, Inc.
The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended actions for the E-5 error code in the labeling do not: (a) clearly emphasize that an E-5 error code could represent a very high blood glucose level, and (b) prominently convey the appropriate immediate actions, such as contacting a healthcare professional. This could lead to a delay in treatment if the user does not seek medical attention immediately when receiving an E-5 error code and experiencing symptoms of high glucose.
Z-1547-2026Open, ClassifiedTrividia Health, Inc.
The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended actions for the E-5 error code in the labeling do not: (a) clearly emphasize that an E-5 error code could represent a very high blood glucose level, and (b) prominently convey the appropriate immediate actions, such as contacting a healthcare professional. This could lead to a delay in treatment if the user does not seek medical attention immediately when receiving an E-5 error code and experiencing symptoms of high glucose.
Z-1548-2026Open, ClassifiedTrividia Health, Inc.
The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended actions for the E-5 error code in the labeling do not: (a) clearly emphasize that an E-5 error code could represent a very high blood glucose level, and (b) prominently convey the appropriate immediate actions, such as contacting a healthcare professional. This could lead to a delay in treatment if the user does not seek medical attention immediately when receiving an E-5 error code and experiencing symptoms of high glucose.
Z-0413-2026Open, ClassifiedTrividia Health, Inc.
Manufacturing defect causing LCD display issues with missing or partial segments (ghosting) that can result in misreading glucose values, potentially leading to inappropriate treatment decisions for diabetes management.
Showing the 5 most recently initiated of 137. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for NBW?
MAUDE holds 17,504 adverse-event reports naming product code NBW, 3,029 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in NBW unusual?
Every month with enough history behind it falls inside NBW's own expected range. Nothing here is unusual for this code.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 688 | Insufficient history | No expected range — too little history | |
| 671 | Insufficient history | No expected range — too little history | |
| 736 | Insufficient history | No expected range — too little history | |
| 509 | Insufficient history | No expected range — too little history | |
| 656 | Insufficient history | No expected range — too little history | |
| 594 | Insufficient history | No expected range — too little history | |
| 447 | Insufficient history | No expected range — too little history | |
| 575 | Insufficient history | No expected range — too little history | |
| 466 | Insufficient history | No expected range — too little history | |
| 658 | Insufficient history | No expected range — too little history | |
| 553 | Insufficient history | No expected range — too little history | |
| 453 | Insufficient history | No expected range — too little history | |
| 657 | Insufficient history | No expected range — too little history | |
| 544 | Insufficient history | No expected range — too little history | |
| 374 | Insufficient history | No expected range — too little history | |
| 566 | Insufficient history | No expected range — too little history | |
| 473 | Insufficient history | No expected range — too little history | |
| 469 | Insufficient history | No expected range — too little history | |
| 507 | Insufficient history | No expected range — too little history | |
| 479 | Insufficient history | No expected range — too little history | |
| 487 | Insufficient history | No expected range — too little history | |
| 377 | 274–623 | Within expected (274–623) | |
| 368 | 232–510 | Within expected (232–510) | |
| 361 | 264–562 | Within expected (264–562) | |
| 369 | 251–576 | Within expected (251–576) | |
| 404 | 287–459 | Within expected (287–459) | |
| 389 | 322–467 | Within expected (322–467) | |
| 376 | 507–734 | Below expected (507–734) | |
| 415 | 282–542 | Within expected (282–542) | |
| 413 | 297–573 | Within expected (297–573) | |
| 428 | 287–564 | Within expected (287–564) | |
| 361 | 264–505 | Within expected (264–505) | |
| 363 | 291–545 | Within expected (291–545) | |
| 491 | 318–606 | Within expected (318–606) | |
| 370 | 278–520 | Within expected (278–520) | |
| 298 | 304–550 | Below expected (304–550) |
21 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike. Method: ewma_alpha_0.3_sd_2 corpus_adjusted. Counts are divided by the corpus-wide volume for that month before comparison, so a rise across all of MAUDE is not reported as a rise in NBW.
What are the predicate devices in NBW?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in NBW?
Across the 509 most recent decisions, these applicants filed most often in NBW.
| Applicant | Recent clearances |
|---|---|
| Taidoc Technology Corporation | 65 |
| I-Sens, Inc. | 21 |
| Abbott Diabetes Care, Inc. | 18 |
| Apex BioTechnology Corp. | 18 |
| Bionime Corporation | 18 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
2 companies in NBW file under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| Abbott Diabetes Care, Inc. | 19 | 2 |
| Roche Diagnostics Corporation | 19 | 3 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch NBW
Get an email the morning anything changes in NBW — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.