510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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CAPClass II

Monitor, Airway Pressure (Includes Gauge And/Or Alarm)

21 CFR 868.2600 / Anesthesiology
FDA source (opens on fda.gov)

CAP is the FDA product code for Monitor, Airway Pressure (Includes Gauge And/Or Alarm), a class II device type, regulated under 21 CFR 868.2600. As of , FDA records hold 78 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
CAP
Device name
Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
Regulation
21 CFR 868.2600
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
78
Ingested recalls
0

Clearances, product code CAP

By decision year
78 clearances under product code CAP with a decision year between 1978 and 2020, 1980 the highest year at 7.
Show the numbers
510(k) clearances under FDA product code CAP by decision year
YearClearances
19783
19794
19807
19817
19824
19831
19842
19854
19862
19875
19895
19903
19911
19921
19933
19942
19951
19962
19981
20003
20021
20041
20051
20081
20101
20112
20121
20132
20141
20151
20161
20181
20192
20201

Applicants with the most clearances

Product code CAP
Applicants holding the most 510(k) clearances under product code CAP
ApplicantClearances
Canadian Monaghan, Ltd.5
Intersect Medical Products, Inc.4
Draeger, Inc.3
Penlon, Ltd.3
Vortran Medical Technology 1, Inc3
Bio-Med Devices, Inc.2
Caradyne, Ltd.2
Core-M, Inc.2
Ferguson Medical2
Hudson Oxygen Therapy Sales Co.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 54 companies shown, in name order