FDA product code CAX: Flowmeter, Tube, Thorpe, Back-Pressure Compensated
CAX is the FDA product code for flowmeter, tube, thorpe, back-pressure compensated. It is a Class I device, regulated under 21 CFR 868.2340 and reviewed by the Anesthesiology panel. FDA has cleared 24 510(k) submissions under CAX, from 16 different applicants. The average 510(k) review took 50 days (median 27). FDA has posted 1 recall for CAX devices.
Classification
| Field | Value |
|---|---|
| Device name | Flowmeter, Tube, Thorpe, Back-Pressure Compensated |
| Device class | Class I |
| Regulation | 21 CFR 868.2340 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every CAX clearance
Top CAX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Timeter Instrument Corp. | 6 | 1981-09-21 |
| Precision Medical, Inc. | 3 | 1985-10-29 |
| Precision Metering, Inc. | 2 | 1984-01-10 |
| Porter Instrument Co., Inc. | 1 | 1993-06-10 |
| Ohmeda Medical | 1 | 1991-04-12 |
11 more applicants have CAX clearances. See the full list in Caduvo.
Most recent CAX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K923781 | Porter Instrument Co., Inc. | MXR-2000 FLOWMETER | 1993-06-10 | 317 |
| K910316 | Ohmeda Medical | OHMEDA - LOW FLOW FLOWMETER | 1991-04-12 | 78 |
| K884973 | Key Instruments | FR6000 FLOWMETER | 1989-01-17 | 48 |
| K872718 | Puritan Bennett Corp. | SERIES D FLOWMETER | 1987-08-05 | 26 |
| K871452 | The Timeter Group | CLASSIC (TM) 200 OXYGEN FLOWMETER | 1987-06-22 | 70 |
Recalls for CAX devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2008-08-26.
Frequently asked questions
What is FDA product code CAX?
CAX is the FDA product code for flowmeter, tube, thorpe, back-pressure compensated. It is a Class I device, regulated under 21 CFR 868.2340 and reviewed by the Anesthesiology panel.
What device class is CAX?
Class I, regulation 21 CFR 868.2340. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code CAX?
Across 24 cleared submissions the average was 50 days from receipt to decision (median 27).
Which companies have the most CAX clearances?
Timeter Instrument Corp. (6); Precision Medical, Inc. (3); Precision Metering, Inc. (2); Porter Instrument Co., Inc. (1); Ohmeda Medical (1).
Have CAX devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2008-08-26.
Next steps
- Run an FDA pathway report with predicate devices for product code CAX
- Run a recall and safety report across every CAX manufacturer
- Watch product code CAX 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.
All Anesthesiology product codes · FDA product code lookup · 510(k) database search · 510(k) review times