510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K022750Substantially Equivalent

Plv Continuum Ventilator, Model P1000

Respironics, Inc., Carlsbad CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K022750 is the FDA 510(k) clearance record for PLV CONTINUUM VENTILATOR, MODEL P1000, a class II device, cleared for Respironics California, Inc. on under FDA product code NOU (Continuous, Ventilator, Home Use). FDA's definition for product code NOU reads: "This product code was needed for the home use indication. CBK is not a tracked device and NOU is a tracked device". FDA records list 186 510(k) clearances for RESPIRONICS, INC., from to . As of , FDA records show 2 recalls naming K022750.

Clearance record

Decision date
Received
(458 days to decision)
Product code
NOU Continuous, Ventilator, Home Use
Regulation
21 CFR 868.5895
Device class
Class II
Review panel
Anesthesiology
Applicant
Respironics California, Inc. 2271 Cosmos Ct., Carlsbad CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NOU

Trailing 12 months

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

FDA records show no clearances under product code NOU in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NOU, 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