510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K900164Substantially Equivalent

Airway Delivery & Management (Adam) Nasal Ventila.

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

K900164 is the FDA 510(k) clearance record for AIRWAY DELIVERY & MANAGEMENT (ADAM) NASAL VENTILA., a class II device, cleared for Puritan Bennett Corp. on under FDA product code BYE (Attachment, Breathing, Positive End Expiratory Pressure). FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show no recalls naming K900164.

Clearance record

Decision date
Received
(14 days to decision)
Product code
BYE Attachment, Breathing, Positive End Expiratory Pressure
Regulation
21 CFR 868.5965
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 BYE

Trailing 12 months

FDA records hold no clearances under product code BYE in the trailing twelve months.

FDA records show no clearances under product code BYE in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code BYE, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260