510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K942210Substantially Equivalent

Puritan-Bennett 335 Respiratory Support System

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

K942210 is the FDA 510(k) clearance record for PURITAN-BENNETT 335 RESPIRATORY SUPPORT SYSTEM, a class II device, cleared for Puritan Bennett Corp. on under FDA product code MNS (Ventilator, Continuous, Non-Life-Supporting). FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show no recalls naming K942210.

Clearance record

Decision date
Received
(647 days to decision)
Product code
MNS Ventilator, Continuous, Non-Life-Supporting
Regulation
21 CFR 868.5895
Device class
Class II
Review panel
Anesthesiology
Applicant
Puritan Bennett Corp. 10800 Pflumm Rd., Lenexa KS
510(k) summary
Summary
Third party review
No

Clearances, product code MNS

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