FDA product code CAP: Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
CAP is the FDA product code for monitor, airway pressure (includes gauge and/or alarm). It is a Class II device, regulated under 21 CFR 868.2600 and reviewed by the Anesthesiology panel. FDA has cleared 78 510(k) submissions under CAP, from 53 different applicants. The average 510(k) review took 106 days (median 66). 1 PMA application cites this product code.
Classification
| Field | Value |
|---|---|
| Device name | Monitor, Airway Pressure (Includes Gauge And/Or Alarm) |
| Device class | Class II |
| Regulation | 21 CFR 868.2600 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for CAP
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 196 |
| 2019 | 2 | 410 |
| 2020 | 1 | 147 |
Compare with all 510(k) review times · Search every CAP clearance
Top CAP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Canadian Monaghan , Ltd. | 5 | 1993-07-01 |
| Intersect Medical Products, Inc. | 4 | 1980-01-09 |
| Vortran Medical Technology 1, Inc. | 3 | 2019-09-18 |
| Penlon, Inc. | 3 | 1990-08-17 |
| Draeger Medical, Inc. | 3 | 1986-05-09 |
48 more applicants have CAP clearances. See the full list in Caduvo.
Most recent CAP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K201666 | Flexicare Medical Limited. | SINGLE USE MANOMETER | 2020-11-13 | 147 |
| K182292 | Vortran Medical Technology 1, Inc. | VORTRAN APM-Plus | 2019-09-18 | 391 |
| K180510 | Instrumentation Industries, Inc. | NS 120P-TRS Airway Pressure Gauge | 2019-05-01 | 428 |
| K172284 | Drw Medical, LLC | NAPA LP-15 Airway Pressure Monitor | 2018-02-09 | 196 |
| K153733 | Vortran Medical Technology 1, Inc. | VORTRAN Manometer | 2016-09-16 | 263 |
Recalls for CAP devices
openFDA lists no recalls for product code CAP.
Frequently asked questions
What is FDA product code CAP?
CAP is the FDA product code for monitor, airway pressure (includes gauge and/or alarm). It is a Class II device, regulated under 21 CFR 868.2600 and reviewed by the Anesthesiology panel.
What device class is CAP?
Class II, regulation 21 CFR 868.2600. Typical premarket route: 510(k).
How long does a 510(k) take for product code CAP?
Across 78 cleared submissions the average was 106 days from receipt to decision (median 66).
Which companies have the most CAP clearances?
Canadian Monaghan , Ltd. (5); Intersect Medical Products, Inc. (4); Vortran Medical Technology 1, Inc. (3); Penlon, Inc. (3); Draeger Medical, Inc. (3).
Next steps
- Run an FDA pathway report with predicate devices for product code CAP
- Run a recall and safety report across every CAP manufacturer
- Watch product code CAP 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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