510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K090804Substantially Equivalent

Nasal Aire II Pediatric, Model 5 Sizes, Model Tbd

Innomed Technologies, Inc./Respcare, Inc., Coconut Creek FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K090804 is the FDA 510(k) clearance record for NASAL AIRE II PEDIATRIC, MODEL 5 SIZES, MODEL TBD, a class II device, cleared for Innomed Technologies, Inc./Respcare, Inc. on under FDA product code BZD (Ventilator, Non-Continuous (Respirator)). FDA records list 2 510(k) clearances for Innomed Technologies, Inc./Respcare, Inc., from to . As of , FDA records show no recalls naming K090804.

Clearance record

Decision date
Received
(225 days to decision)
Product code
BZD Ventilator, Non-Continuous (Respirator)
Regulation
21 CFR 868.5905
Device class
Class II
Review panel
Anesthesiology
Applicant
Innomed Technologies, Inc./Respcare, Inc. 6601 Lyons Rd., Suites B1-B4, Coconut Creek FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code BZD

Trailing 12 months
11 clearances under product code BZD in the twelve months to October 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code BZD, trailing twelve months
MonthClearances
November 20250
December 20252
January 20262
February 20260
March 20260
April 20262
May 20262
June 20261
July 20261
August 20260
September 20261
October 20260