510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K910194Substantially Equivalent

Companion 318 Nasal CPAP Diagnostics System

Medtronic, Inc., Overland Park KS / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K910194 is the FDA 510(k) clearance record for COMPANION 318 NASAL CPAP DIAGNOSTICS SYSTEM, a class II device, cleared for Puritan Bennett Corp. on under FDA product code BZD (Ventilator, Non-Continuous (Respirator)). FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show no recalls naming K910194.

Clearance record

Decision date
Received
(117 days to decision)
Product code
BZD Ventilator, Non-Continuous (Respirator)
Regulation
21 CFR 868.5905
Device class
Class II
Review panel
Anesthesiology
Applicant
Puritan Bennett Corp. 9401 Indian Creek Pkwy., Overland Park KS
Third party review
No

Clearances, product code BZD

Trailing 12 months
12 clearances under product code BZD in the twelve months to November 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code BZD, trailing twelve months
MonthClearances
December 20252
January 20262
February 20260
March 20260
April 20262
May 20262
June 20261
July 20261
August 20260
September 20261
October 20261
November 20260