510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K863171Substantially Equivalent

Respironics Protecteasy

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

K863171 is the FDA 510(k) clearance record for RESPIRONICS PROTECTEASY, a class I device, cleared for Respironics, Inc. on under FDA product code KGK (Gas, Collecting Vessel). FDA records list 186 510(k) clearances for Respironics, Inc., from to . As of , FDA records show no recalls naming K863171.

Clearance record

Decision date
Received
(58 days to decision)
Product code
KGK Gas, Collecting Vessel
Regulation
21 CFR 868.1575
Device class
Class I
Review panel
Anesthesiology
Applicant
Respironics, Inc. 530 Seco Rd., Monroeville PA
Third party review
No

Clearances, product code KGK

Trailing 12 months

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

FDA records show no clearances under product code KGK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KGK, 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