510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K902276Substantially Equivalent

Respironics BIPAP Pressure Alarm (BIPAP P.a.)

Respironics, Inc., Murrysville PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K902276 is the FDA 510(k) clearance record for RESPIRONICS BIPAP PRESSURE ALARM (BIPAP P.A.), a class II device, cleared for Respironics, Inc. on under FDA product code CAP (Monitor, Airway Pressure (Includes Gauge And/Or Alarm)). FDA records list 186 510(k) clearances for Respironics, Inc., from to . As of , FDA records show no recalls naming K902276.

Clearance record

Decision date
Received
(88 days to decision)
Product code
CAP Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
Regulation
21 CFR 868.2600
Device class
Class II
Review panel
Anesthesiology
Applicant
Respironics, Inc. 1001 Murry Ridge Ln., Murrysville PA
Third party review
No

Clearances, product code CAP

Trailing 12 months

FDA records hold no clearances under product code CAP in the trailing twelve months.

FDA records show no clearances under product code CAP in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code CAP, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260