510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K963550Substantially Equivalent

Rinoflow Micronized e.n..t. Wash Sytstem

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

K963550 is the FDA 510(k) clearance record for RINOFLOW MICRONIZED E.N..T. WASH SYTSTEM, a class I device, cleared for Respironics, Inc. on under FDA product code KMA (Irrigator, Powered Nasal). FDA records list 186 510(k) clearances for Respironics, Inc., from to . As of , FDA records show no recalls naming K963550.

Clearance record

Decision date
Received
(57 days to decision)
Product code
KMA Irrigator, Powered Nasal
Regulation
21 CFR 874.5550
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Respironics, Inc. 1001 Murry Ridge Ln., Murrysville PA
510(k) summary
Summary
Third party review
No

Clearances, product code KMA

Trailing 12 months

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

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