CCLClass II
Analyzer, Gas, Oxygen, Gaseous-Phase
21 CFR 868.1720 / Anesthesiology
CCL is the FDA product code for Analyzer, Gas, Oxygen, Gaseous-Phase, a class II device type, regulated under 21 CFR 868.1720. As of , FDA records hold 122 510(k) clearances under this code, the most recent dated , and 5 recalls.
Classification record
- Product code
- CCL
- Device name
- Analyzer, Gas, Oxygen, Gaseous-Phase
- Regulation
- 21 CFR 868.1720
- Device class
- Class II
- Review panel
- Anesthesiology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 122
- Ingested recalls
- 5
Clearances, product code CCL
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1976 | 1 |
| 1977 | 2 |
| 1978 | 2 |
| 1979 | 6 |
| 1980 | 3 |
| 1981 | 7 |
| 1982 | 5 |
| 1983 | 7 |
| 1984 | 5 |
| 1985 | 5 |
| 1986 | 4 |
| 1987 | 3 |
| 1988 | 9 |
| 1989 | 5 |
| 1990 | 2 |
| 1991 | 2 |
| 1992 | 2 |
| 1993 | 2 |
| 1994 | 2 |
| 1995 | 5 |
| 1996 | 4 |
| 1997 | 1 |
| 1998 | 5 |
| 1999 | 4 |
| 2000 | 4 |
| 2001 | 3 |
| 2003 | 3 |
| 2004 | 2 |
| 2005 | 1 |
| 2006 | 1 |
| 2007 | 2 |
| 2008 | 2 |
| 2011 | 1 |
| 2013 | 2 |
| 2016 | 1 |
| 2018 | 1 |
| 2022 | 2 |
| 2023 | 1 |
| 2025 | 2 |
| 2026 | 1 |
Applicants with the most clearances
Product code CCL| Applicant | Clearances |
|---|---|
| Maxtec, LLC | 5 |
| Salter Labs | 5 |
| Catalyst Research Corp. | 4 |
| Ceramatec, Inc. | 4 |
| Vascular Technology Incorporated | 4 |
| Analytical Industries, Inc. | 3 |
| Hewlett-Packard Co. | 3 |
| GE Healthcare | 3 |
| Teledyne Analytical Instruments | 3 |
| Bio-Med Devices, Inc. | 2 |
Companies listing this code with FDA
Companies whose registered establishments list this code- AD Supply Group Limited
- Advanced Instrumentations, Inc.
- Aei Technologies Inc.
- Airgas Therapeutics LLC
- AirLife Finland Oy
- Amphenol Cable and Interconnect Technologies Asia Pacific Ltd.
- Amphenol Medical Technologies (Dongguan) Co., Ltd.
- Analytical Industries, Inc.
- Bio-Med Devices, Inc.
- Bluepoint Medical GmbH & Co. KG
- Caf Medical Solutions Inc
- CBR Enterprise Limited
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
