510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K082660Substantially Equivalent

V60 Ventilator, Model V8000

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

K082660 is the FDA 510(k) clearance record for V60 VENTILATOR, MODEL V8000, a class II device, cleared for Respironics California, Inc. on under FDA product code MNT (Sv70 Ventilator). FDA records list 186 510(k) clearances for RESPIRONICS, INC., from to . As of , FDA records show 44 recalls naming K082660.

Clearance record

Decision date
Received
(119 days to decision)
Product code
MNT Continuous, Minimal Ventilatory Support, Facility Use Ventilator
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 MNT

Trailing 12 months
1 clearance under product code MNT in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MNT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260