FDA product code CCL: Analyzer, Gas, Oxygen, Gaseous-Phase
CCL is the FDA product code for analyzer, gas, oxygen, gaseous-phase. It is a Class II device, regulated under 21 CFR 868.1720 and reviewed by the Anesthesiology panel. FDA has cleared 122 510(k) submissions under CCL, 6 in the last five years, from 87 different applicants. The average 510(k) review took 118 days (median 86); 102 days on average over the last three years. FDA has posted 5 recalls for CCL devices.
Classification
| Field | Value |
|---|---|
| Device name | Analyzer, Gas, Oxygen, Gaseous-Phase |
| Device class | Class II |
| Regulation | 21 CFR 868.1720 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for CCL
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 138 |
| 2022 | 2 | 168 |
| 2023 | 1 | 290 |
| 2025 | 2 | 112 |
| 2026 | 1 | 93 |
Compare with all 510(k) review times · Search every CCL clearance
Top CCL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Salter Labs | 5 | 2026-07-30 |
| Ceramatec, Inc. | 4 | 1998-03-30 |
| Vascular Technology Incorporated | 4 | 1993-01-27 |
| Catalyst Research Corp. | 4 | 1983-12-12 |
| Maxtec, LLC | 3 | 2023-04-01 |
82 more applicants have CCL clearances. See the full list in Caduvo.
Most recent CCL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261389 | Salter Labs | PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1) | 2026-07-30 | 93 |
| K251245 | Bio-Med Device, Inc. | OxyMinder Pro (10310) | 2025-08-11 | 111 |
| K250002 | Life Spark Medical, LLC | Smart Check O2 (MA0236) | 2025-04-24 | 112 |
| K221734 | Maxtec, LLC | Maxtec MaxO2 ME+p | 2023-04-01 | 290 |
| K213933 | Careox, LLC | Percent Oxygen Sensors | 2022-08-19 | 246 |
Recalls for CCL devices
5 product recalls in 5 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2015-04-24.
Frequently asked questions
What is FDA product code CCL?
CCL is the FDA product code for analyzer, gas, oxygen, gaseous-phase. It is a Class II device, regulated under 21 CFR 868.1720 and reviewed by the Anesthesiology panel.
What device class is CCL?
Class II, regulation 21 CFR 868.1720. Typical premarket route: 510(k).
How long does a 510(k) take for product code CCL?
Across 122 cleared submissions the average was 118 days from receipt to decision (median 86).
Which companies have the most CCL clearances?
Salter Labs (5); Ceramatec, Inc. (4); Vascular Technology Incorporated (4); Catalyst Research Corp. (4); Maxtec, LLC (3).
Have CCL devices been recalled?
Yes: 5 product recalls across 5 recall events; the most recent began 2015-04-24.
Next steps
- Run an FDA pathway report with predicate devices for product code CCL
- Run a recall and safety report across every CCL manufacturer
- Watch product code CCL 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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