FDA product code KMS: Phenolphthalein Colorimetry, Carbon-Dioxide
KMS is the FDA product code for phenolphthalein colorimetry, carbon-dioxide. It is a Class II device, regulated under 21 CFR 862.1160 and reviewed by the Clinical Chemistry panel. FDA has cleared 5 510(k) submissions under KMS, from 5 different applicants. The average 510(k) review took 44 days (median 34).
Classification
| Field | Value |
|---|---|
| Device name | Phenolphthalein Colorimetry, 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 |
Compare with all 510(k) review times · Search every KMS clearance
Top KMS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Catachem, Inc. | 1 | 1987-08-13 |
| American Research Products Co. | 1 | 1987-03-13 |
| Panmed, Inc. | 1 | 1980-10-10 |
| Diagnostic Solutions, Inc. | 1 | 1980-05-30 |
| Gamma Enterprises, Inc. | 1 | 1978-05-03 |
Most recent KMS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K872886 | Catachem, Inc. | CARBON DIOXIDE | 1987-08-13 | 22 |
| K870025 | American Research Products Co. | AMRESCO FLOW PAC CARBON DIOXIDE (CO2) REAGENTS | 1987-03-13 | 67 |
| K802162 | Panmed, Inc. | CO2 COLOR REAGENT & CO2 SAMPLE DILUENT | 1980-10-10 | 32 |
| K800681 | Diagnostic Solutions, Inc. | REAGENTS FOR DETERM. CO2 IN HUMAN SERUM | 1980-05-30 | 65 |
| K780506 | Gamma Enterprises, Inc. | CARBON DIOXIDE REAGENTS | 1978-05-03 | 34 |
Recalls for KMS devices
openFDA lists no recalls for product code KMS.
Frequently asked questions
What is FDA product code KMS?
KMS is the FDA product code for phenolphthalein colorimetry, 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 KMS?
Class II, regulation 21 CFR 862.1160. Typical premarket route: 510(k).
How long does a 510(k) take for product code KMS?
Across 5 cleared submissions the average was 44 days from receipt to decision (median 34).
Which companies have the most KMS clearances?
Catachem, Inc. (1); American Research Products Co. (1); Panmed, Inc. (1); Diagnostic Solutions, Inc. (1); Gamma Enterprises, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KMS
- Run a recall and safety report across every KMS manufacturer
- Watch product code KMS 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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