FDA product code CCN: Flowmeter, Nonback-Pressure Compensated, Bourdon Gauge
CCN is the FDA product code for flowmeter, nonback-pressure compensated, bourdon gauge. It is a Class I device, regulated under 21 CFR 868.2300 and reviewed by the Anesthesiology panel. FDA has cleared 9 510(k) submissions under CCN, from 6 different applicants. The average 510(k) review took 78 days (median 75). FDA has posted 1 recall for CCN devices.
Classification
| Field | Value |
|---|---|
| Device name | Flowmeter, Nonback-Pressure Compensated, Bourdon Gauge |
| Device class | Class I |
| Regulation | 21 CFR 868.2300 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every CCN clearance
Top CCN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Design Technologies, Inc. | 3 | 1987-08-10 |
| Salter Labs | 2 | 1986-10-15 |
| Cardio-Search , Ltd. | 1 | 1993-11-17 |
| Puritan Bennett Corp. | 1 | 1992-09-18 |
| Timeter Instrument Corp. | 1 | 1983-01-14 |
1 more applicants have CCN clearances. See the full list in Caduvo.
Most recent CCN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K934945 | Cardio-Search , Ltd. | FLOWMETER NIPPLE ADAPTOR | 1993-11-17 | 35 |
| K920783 | Puritan Bennett Corp. | OXYGEN FLOW CONTROLLER | 1992-09-18 | 211 |
| K872038 | Design Technologies, Inc. | NEB-U-VENT | 1987-08-10 | 75 |
| K871262 | Design Technologies, Inc. | MODIFIED NOFLO I | 1987-07-21 | 112 |
| K863613 | Design Technologies, Inc. | NO-FLO I | 1986-12-15 | 90 |
Recalls for CCN devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2009-05-29.
Frequently asked questions
What is FDA product code CCN?
CCN is the FDA product code for flowmeter, nonback-pressure compensated, bourdon gauge. It is a Class I device, regulated under 21 CFR 868.2300 and reviewed by the Anesthesiology panel.
What device class is CCN?
Class I, regulation 21 CFR 868.2300. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code CCN?
Across 9 cleared submissions the average was 78 days from receipt to decision (median 75).
Which companies have the most CCN clearances?
Design Technologies, Inc. (3); Salter Labs (2); Cardio-Search , Ltd. (1); Puritan Bennett Corp. (1); Timeter Instrument Corp. (1).
Have CCN devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2009-05-29.
Next steps
- Run an FDA pathway report with predicate devices for product code CCN
- Run a recall and safety report across every CCN manufacturer
- Watch product code CCN 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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