FDA product code · Clinical Chemistry
JKATubes, Vials, Systems, Serum Separators, Blood Collection
Product code JKA covers Tubes, Vials, Systems, Serum Separators, Blood Collection, a Class II device regulated under 21 CFR 862.1675. FDA has cleared 236 devices in this code, 6 of them in the last 12 months. Median review time across the 236 most recent decisions is 91 days. openFDA lists 170 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 862.1675
- Review panel
- Clinical Chemistry
- Clearances
- 236
What is happening in JKA right now?
JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection) has three findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class II) (Z-1100-2026, Z-0544-2026, Z-0545-2026, Z-0546-2026, Z-0547-2026). 1 first-time filer in the last 12 months, Zhejiang Kindly Medical Device Co., Ltd (K252899). The code is crowded, scoring 75 of 100 — 113 companies hold a clearance here and 6 arrived in the last 12 months (JKA:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-1100-2026, Z-0544-2026, Z-0545-2026, Z-0546-2026, Z-0547-2026 |
| New entrant | Worth knowing | K252899 |
| Crowding | Context | JKA: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 JKA?
FDA has cleared 236 devices under product code JKA since the 510(k) programme began in 1976, 6 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252899 | Female Culture Device; Male Culture Device; Transfer Device; Access Device | Zhejiang Kindly Medical Device Co., Ltd. | |
| K260128 | BD Preset and BD A-Line Arterial Blood Collection Syringes | Becton, Dickinson and Company | |
| K252506 | BD Vacutainer® Safety-Lok Blood Collection Set; BD Vacutainer® Safety-Lok Blood Collection Set with Pre-Attached Holder | Becton, Dickinson and Company | |
| K252378 | BD® MiniDraw Capillary Blood Collection System with BD® MiniDraw SST Capillary Blood Collection Tube | Becton, Dickinson and Company | |
| K252040 | BD Vacutainer® Plasma Separator Tubes (PST), BD Vacutainer® Sodium Heparin Blood Collection Tubes | Becton, Dickinson and Company | |
| K251812 | Steripath® Flow Blood Collection System | Magnolia Medical Technologies | |
| K243207 | BD Vacutainer® Eclipse Blood Collection Needle | Becton, Dickinson and Company | |
| K250961 | Blood collection tube holders | Promisemed Hangzhou Meditech Co., Ltd. | |
| K244047 | Navi Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG) | Venocare, Inc. | |
| K250907 | Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set | Sol-Millennium Medical, Inc. |
How long does FDA review take for JKA?
The median FDA review time for JKA is 91 days, measured across the 236 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 JKA?
openFDA lists 170 recall records against product code JKA. A recall record covers one firm's corrective action and may span many device lots.
Z-1100-2026Open, ClassifiedICU Medical, Inc.
Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may also lead to blood leakage during sampling of arterial blood or leakage during fluid delivery.
Z-0544-2026Open, ClassifiedASP Global, LLC. dba Anatomy Supply Partners, LLC.
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Z-0545-2026Open, ClassifiedASP Global, LLC. dba Anatomy Supply Partners, LLC.
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Z-0546-2026Open, ClassifiedASP Global, LLC. dba Anatomy Supply Partners, LLC.
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Z-0547-2026Open, ClassifiedASP Global, LLC. dba Anatomy Supply Partners, LLC.
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Showing the 5 most recently initiated of 170. 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 JKA?
MAUDE holds 14,964 adverse-event reports naming product code JKA, 4,071 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 JKA unusual?
One month sits above JKA's own expected range: 1 September 2025.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 346 | Insufficient history | No expected range — too little history | |
| 255 | Insufficient history | No expected range — too little history | |
| 302 | Insufficient history | No expected range — too little history | |
| 361 | Insufficient history | No expected range — too little history | |
| 359 | Insufficient history | No expected range — too little history | |
| 440 | Insufficient history | No expected range — too little history | |
| 337 | Insufficient history | No expected range — too little history | |
| 418 | Insufficient history | No expected range — too little history | |
| 217 | Insufficient history | No expected range — too little history | |
| 381 | Insufficient history | No expected range — too little history | |
| 322 | Insufficient history | No expected range — too little history | |
| 536 | Insufficient history | No expected range — too little history | |
| 410 | Insufficient history | No expected range — too little history | |
| 405 | Insufficient history | No expected range — too little history | |
| 355 | Insufficient history | No expected range — too little history | |
| 336 | Insufficient history | No expected range — too little history | |
| 374 | Insufficient history | No expected range — too little history | |
| 365 | Insufficient history | No expected range — too little history | |
| 299 | Insufficient history | No expected range — too little history | |
| 393 | Insufficient history | No expected range — too little history | |
| 434 | Insufficient history | No expected range — too little history | |
| 303 | 208–493 | Within expected (208–493) | |
| 367 | 164–420 | Within expected (164–420) | |
| 466 | 210–500 | Within expected (210–500) | |
| 480 | 276–524 | Within expected (276–524) | |
| 485 | 268–526 | Within expected (268–526) | |
| 415 | 282–596 | Within expected (282–596) | |
| 513 | 427–928 | Within expected (427–928) | |
| 392 | 293–657 | Within expected (293–657) | |
| 789 | 283–665 | Above expected (283–665) | |
| 597 | 305–821 | Within expected (305–821) | |
| 505 | 308–729 | Within expected (308–729) | |
| 690 | 342–799 | Within expected (342–799) | |
| 473 | 420–976 | Within expected (420–976) | |
| 357 | 310–760 | Within expected (310–760) | |
| 376 | 257–802 | Within expected (257–802) |
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 JKA.
Who has entered JKA in the last year?
One company filed in JKA for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Zhejiang Kindly Medical Device Co., Ltd. | K252899 |
"First time" means their first clearance in this product code, not their first ever — an established manufacturer entering a new category is exactly the movement worth knowing about.
Source: openFDA device/510k · retrieved
What are the predicate devices in JKA?
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 JKA?
Across the 236 most recent decisions, these applicants filed most often in JKA.
| Applicant | Recent clearances |
|---|---|
| Becton, Dickinson and Company | 18 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 13 |
| Becton Dickinson Vacutainer Systems | 11 |
| Sherwood Medical Co. | 9 |
| Becton, Dickinson & CO | 8 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
One company in JKA files 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 |
|---|---|---|
| Becton, Dickinson and Company | 26 | 2 |
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 JKA
Get an email the morning anything changes in JKA — 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.