510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K923590Substantially Equivalent

318A Respiratory Support System

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

K923590 is the FDA 510(k) clearance record for 318A RESPIRATORY SUPPORT 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 K923590.

Clearance record

Decision date
Received
(263 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. 10800 Pflumm Rd., Lenexa KS
510(k) summary
Statement
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