510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K863172Substantially Equivalent

Respironics Ptl Reviveeasy

Respironics, Inc., Monroeville PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K863172 is the FDA 510(k) clearance record for RESPIRONICS PTL REVIVEEASY, a class II device, cleared for Respironics, Inc. on under FDA product code CAO (Airway, Esophageal (Obturator)). FDA records list 186 510(k) clearances for Respironics, Inc., from to . As of , FDA records show no recalls naming K863172.

Clearance record

Decision date
Received
(78 days to decision)
Product code
CAO Airway, Esophageal (Obturator)
Regulation
21 CFR 868.5650
Device class
Class II
Review panel
Anesthesiology
Applicant
Respironics, Inc. 530 Seco Rd., Monroeville PA
Third party review
No

Clearances, product code CAO

Trailing 12 months

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

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