FDA product code KHS: Enzymatic, Carbon-Dioxide
KHS is the FDA product code for enzymatic, carbon-dioxide. It is a Class II device, regulated under 21 CFR 862.1160 and reviewed by the Clinical Chemistry panel. FDA has cleared 86 510(k) submissions under KHS, from 49 different applicants. The average 510(k) review took 86 days (median 58). FDA has posted 7 recalls for KHS devices, 5 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Enzymatic, Carbon-Dioxide |
| Device class | Class II |
| Regulation | 21 CFR 862.1160 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for KHS
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 129 |
Compare with all 510(k) review times · Search every KHS clearance
Top KHS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Em Diagnostic Systems, Inc. | 7 | 1993-08-03 |
| Abbott Laboratories | 4 | 2006-05-04 |
| Diagnostic Chemicals , Ltd. | 4 | 2004-12-27 |
| Data Medical Associates, Inc. | 4 | 1996-02-29 |
| Boehringer Mannheim Corp. | 4 | 1994-12-05 |
44 more applicants have KHS clearances. See the full list in Caduvo.
Most recent KHS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K170200 | Teco Diagnostics, Inc. | Carbon Dioxide Reagent Set | 2017-06-01 | 129 |
| K152085 | Randox Laboratories, Ltd. | Liquid CO2-2 (LCO2-2) | 2016-02-24 | 212 |
| K140248 | Hitachi Chemical Diagnostics, Inc. | S TEST REAGENT CARTRIDGE CARBON DIOXIDE (CO2) | 2014-03-11 | 40 |
| K131546 | Beckman Coulter Ireland, Inc. | AU BICARBONATE REAGENT | 2013-10-09 | 133 |
| K123953 | Alfa Wassermann Diagnostic Technologies, Inc. | ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT | 2013-05-02 | 132 |
Recalls for KHS devices
7 product recalls in 5 recall events; 5 initiated in the last five years and 5 still open. Most recent: 2025-10-14.
| Year | Recalls |
|---|---|
| 2019 | 1 |
| 2023 | 4 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code KHS?
KHS is the FDA product code for enzymatic, carbon-dioxide. It is a Class II device, regulated under 21 CFR 862.1160 and reviewed by the Clinical Chemistry panel.
What device class is KHS?
Class II, regulation 21 CFR 862.1160. Typical premarket route: 510(k).
How long does a 510(k) take for product code KHS?
Across 86 cleared submissions the average was 86 days from receipt to decision (median 58).
Which companies have the most KHS clearances?
Em Diagnostic Systems, Inc. (7); Abbott Laboratories (4); Diagnostic Chemicals , Ltd. (4); Data Medical Associates, Inc. (4); Boehringer Mannheim Corp. (4).
Have KHS devices been recalled?
Yes: 7 product recalls across 5 recall events; the most recent began 2025-10-14.
Next steps
- Run an FDA pathway report with predicate devices for product code KHS
- Run a recall and safety report across every KHS manufacturer
- Watch product code KHS for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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