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
K963633Substantially Equivalent

Ventnet; Central Monitoring Station

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

K963633 is the FDA 510(k) clearance record for VENTNET; CENTRAL MONITORING STATION, a class II device, cleared for Puritan Bennett Corp. on under FDA product code MOD (Accessory To Continuous Ventilator (Respirator)). FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show no recalls naming K963633.

Clearance record

Decision date
Received
(96 days to decision)
Product code
MOD Accessory To Continuous Ventilator (Respirator)
Regulation
21 CFR 868.5895
Device class
Class II
Review panel
Anesthesiology
Applicant
Puritan Bennett Corp. 15222 Del Amo Ave., Tustin CA
510(k) summary
Summary
Third party review
No

Clearances, product code MOD

Trailing 12 months
3 clearances under product code MOD in the twelve months to November 2026, August 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code MOD, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20262
September 20260
October 20260
November 20260