510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K951264Substantially Equivalent

BIPAP Model S/t-D

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

K951264 is the FDA 510(k) clearance record for BIPAP MODEL S/T-D, a class II device, cleared for Respironics, 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 no recalls naming K951264.

Clearance record

Decision date
Received
(496 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, Inc. 1001 Murry Ridge Ln., Murrysville PA
510(k) summary
Summary
Third party review
No

Clearances, product code MNT

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