FDA product code CAT: Cannula, Nasal, Oxygen
CAT is the FDA product code for cannula, nasal, oxygen. It is a Class I device, regulated under 21 CFR 868.5340 and reviewed by the Anesthesiology panel. FDA has cleared 42 510(k) submissions under CAT, from 37 different applicants. The average 510(k) review took 55 days (median 26). FDA has posted 6 recalls for CAT devices.
Classification
| Field | Value |
|---|---|
| Device name | Cannula, Nasal, Oxygen |
| Device class | Class I |
| Regulation | 21 CFR 868.5340 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every CAT clearance
Top CAT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Salter Labs | 3 | 1991-07-24 |
| Alpine Specialties, Inc. | 2 | 1992-08-14 |
| Ashai Co. , Ltd. | 2 | 1985-09-18 |
| Hudson Extrusions, Inc. | 2 | 1984-10-30 |
| Hudson Respiratory Care, Inc. | 1 | 2001-06-13 |
32 more applicants have CAT clearances. See the full list in Caduvo.
Most recent CAT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K011125 | Hudson Respiratory Care, Inc. | NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMILAR NASAL CANNULA MANUFACTURED BY HRCI | 2001-06-13 | 61 |
| K935533 | Puritas Health Care, Inc. | NASAL CANNULA | 1994-02-03 | 79 |
| K922397 | Boston Pacific Medical, Inc. | 4 SURE TM NASAL OXYGEN CANNULA | 1993-03-18 | 301 |
| K921496 | Alpine Specialties, Inc. | SKIN SAVER(TM) TUBING HOLDER, MODEL 1921 MODIFIED | 1992-08-14 | 158 |
| K920573 | B & F Medical Products, Inc. | CANNULA NASAL OXYGEN | 1992-08-11 | 186 |
Recalls for CAT devices
6 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-07-06.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2018 | 5 |
Frequently asked questions
What is FDA product code CAT?
CAT is the FDA product code for cannula, nasal, oxygen. It is a Class I device, regulated under 21 CFR 868.5340 and reviewed by the Anesthesiology panel.
What device class is CAT?
Class I, regulation 21 CFR 868.5340. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code CAT?
Across 42 cleared submissions the average was 55 days from receipt to decision (median 26).
Which companies have the most CAT clearances?
Salter Labs (3); Alpine Specialties, Inc. (2); Ashai Co. , Ltd. (2); Hudson Extrusions, Inc. (2); Hudson Respiratory Care, Inc. (1).
Have CAT devices been recalled?
Yes: 6 product recalls across 2 recall events; the most recent began 2018-07-06.
Next steps
- Run an FDA pathway report with predicate devices for product code CAT
- Run a recall and safety report across every CAT manufacturer
- Watch product code CAT 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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