FDA product code · Clinical Chemistry
CHLElectrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Product code CHL covers Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph, a Class II device regulated under 21 CFR 862.1120. FDA has cleared 188 devices in this code, 1 of them in the last 12 months. Median review time across the 188 most recent decisions is 66 days. openFDA lists 182 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 862.1120
- Review panel
- Clinical Chemistry
- Clearances
- 188
What is happening in CHL right now?
CHL (Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph) has two findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Z-2821-2026, Z-2822-2026, Z-2823-2026, Z-2824-2026, Z-2825-2026). Adverse events reported in 2026-03 ran high — 31 reports against an expected 0 to 31 (CHL:MAUDE:2026-03).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Serious | Z-2821-2026, Z-2822-2026, Z-2823-2026, Z-2824-2026, Z-2825-2026 |
| Adverse-event spike | Serious | CHL:MAUDE:2026-03 |
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 CHL?
FDA has cleared 188 devices under product code CHL since the 510(k) programme began in 1976, 1 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252207 | ABL90 FLEX PLUS System, safeCLINITUBES | Radiometer Medicals Aps | |
| K244014 | i-STAT CG4+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | |
| K240998 | ABL90 FLEX PLUS System | Radiometer Medicals Aps | |
| K230285 | i-STAT CG8+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | |
| K221900 | Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation | |
| K223857 | i-STAT G3+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | |
| K223608 | GEM Premier 7000 with IQM3 | Instrumentation Laboratory Company | |
| K211559 | EasyStat 300 | Medica Corporation | |
| K203790 | GEM Premier 5000 | Instrumentation Laboratory CO | |
| K200986 | OPTI® B-Lac Cassette | Opti Medical Systems, Inc. |
How long does FDA review take for CHL?
The median FDA review time for CHL is 66 days, measured across the 188 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 CHL?
openFDA lists 182 recall records against product code CHL. A recall record covers one firm's corrective action and may span many device lots.
Z-2821-2026Open, ClassifiedInstrumentation Laboratory
BCR wands that received a configuration update (released under Service Information No. 2026-07 on or after April 8, 2026) may assign patient results to an incorrect patient ID. The root cause is a race condition introduced when the "price check" feature was disabled to reduce excess current draw. This causes buffered data from a previous scan to be transmitted instead of the most recent scan, populating a prior patient ID instead of the current one. This can result in erroneous results being attributed to the wrong patient, potentially leading to inappropriate clinical management.
Z-2822-2026Open, ClassifiedInstrumentation Laboratory
BCR wands that received a configuration update (released under Service Information No. 2026-07 on or after April 8, 2026) may assign patient results to an incorrect patient ID. The root cause is a race condition introduced when the "price check" feature was disabled to reduce excess current draw. This causes buffered data from a previous scan to be transmitted instead of the most recent scan, populating a prior patient ID instead of the current one. This can result in erroneous results being attributed to the wrong patient, potentially leading to inappropriate clinical management.
Z-2823-2026Open, ClassifiedInstrumentation Laboratory
BCR wands that received a configuration update (released under Service Information No. 2026-07 on or after April 8, 2026) may assign patient results to an incorrect patient ID. The root cause is a race condition introduced when the "price check" feature was disabled to reduce excess current draw. This causes buffered data from a previous scan to be transmitted instead of the most recent scan, populating a prior patient ID instead of the current one. This can result in erroneous results being attributed to the wrong patient, potentially leading to inappropriate clinical management.
Z-2824-2026Open, ClassifiedInstrumentation Laboratory
BCR wands that received a configuration update (released under Service Information No. 2026-07 on or after April 8, 2026) may assign patient results to an incorrect patient ID. The root cause is a race condition introduced when the "price check" feature was disabled to reduce excess current draw. This causes buffered data from a previous scan to be transmitted instead of the most recent scan, populating a prior patient ID instead of the current one. This can result in erroneous results being attributed to the wrong patient, potentially leading to inappropriate clinical management.
Z-2825-2026Open, ClassifiedInstrumentation Laboratory
BCR wands that received a configuration update (released under Service Information No. 2026-07 on or after April 8, 2026) may assign patient results to an incorrect patient ID. The root cause is a race condition introduced when the "price check" feature was disabled to reduce excess current draw. This causes buffered data from a previous scan to be transmitted instead of the most recent scan, populating a prior patient ID instead of the current one. This can result in erroneous results being attributed to the wrong patient, potentially leading to inappropriate clinical management.
Showing the 5 most recently initiated of 182. 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 CHL?
MAUDE holds 586 adverse-event reports naming product code CHL, 103 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 CHL unusual?
2 months sit above CHL's own expected range: 1 March 2025, 1 March 2026.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 5 | Insufficient history | No expected range — too little history | |
| 11 | Insufficient history | No expected range — too little history | |
| 15 | Insufficient history | No expected range — too little history | |
| 14 | Insufficient history | No expected range — too little history | |
| 16 | Insufficient history | No expected range — too little history | |
| 13 | Insufficient history | No expected range — too little history | |
| 13 | Insufficient history | No expected range — too little history | |
| 23 | Insufficient history | No expected range — too little history | |
| 15 | Insufficient history | No expected range — too little history | |
| 9 | Insufficient history | No expected range — too little history | |
| 11 | Insufficient history | No expected range — too little history | |
| 18 | Insufficient history | No expected range — too little history | |
| 23 | Insufficient history | No expected range — too little history | |
| 17 | Insufficient history | No expected range — too little history | |
| 12 | Insufficient history | No expected range — too little history | |
| 15 | Insufficient history | No expected range — too little history | |
| 18 | Insufficient history | No expected range — too little history | |
| 25 | Insufficient history | No expected range — too little history | |
| 18 | Insufficient history | No expected range — too little history | |
| 14 | Insufficient history | No expected range — too little history | |
| 16 | Insufficient history | No expected range — too little history | |
| 17 | 6–24 | Within expected (6–24) | |
| 16 | 7–21 | Within expected (7–21) | |
| 27 | 9–23 | Above expected (9–23) | |
| 20 | 10–30 | Within expected (10–30) | |
| 24 | 10–27 | Within expected (10–27) | |
| 17 | 11–31 | Within expected (11–31) | |
| 26 | 16–46 | Within expected (16–46) | |
| 11 | 12–33 | Below expected (12–33) | |
| 14 | 7–33 | Within expected (7–33) | |
| 13 | 5–31 | Within expected (5–31) | |
| 8 | 3–27 | Within expected (3–27) | |
| 9 | 0–29 | Within expected (0–29) | |
| 12 | 0–33 | Within expected (0–33) | |
| 10 | 0–28 | Within expected (0–28) | |
| 31 | 0–31 | Above expected (0–31) |
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 CHL.
What are the predicate devices in CHL?
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 CHL?
Across the 188 most recent decisions, these applicants filed most often in CHL.
| Applicant | Recent clearances |
|---|---|
| Nova Biomedical Corp. | 20 |
| Fisher Scientific Co., LLC | 15 |
| Instrumentation Laboratory CO | 15 |
| Radiometer America, Inc. | 15 |
| Radiometer Medical Aps | 13 |
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 CHL 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 |
|---|---|---|
| Nova Biomedical Corporation | 28 | 2 |
| Instrumentation Laboratory | 16 | 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 CHL
Get an email the morning anything changes in CHL — 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.