510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K896136Substantially Equivalent

Infant c.p.a.p. Monitor

Hudson Oxygen Therapy Sales Co., Temecula CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K896136 is the FDA 510(k) clearance record for INFANT C.P.A.P. MONITOR, a class II device, cleared for Hudson Oxygen Therapy Sales Co. on under FDA product code CAP (Monitor, Airway Pressure (Includes Gauge And/Or Alarm)). FDA records list 33 510(k) clearances for Hudson Oxygen Therapy Sales Co., from to . As of , FDA records show no recalls naming K896136.

Clearance record

Decision date
Received
(78 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
Hudson Oxygen Therapy Sales Co. 27711 Diaz St., Temecula CA
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 October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code CAP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260