510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K060497Substantially Equivalent

Babyair

Promedic, Inc., Bonita Springs FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K060497 is the FDA 510(k) clearance record for BABYAIR, a class II device, cleared for Promedic, Inc. on under FDA product code CAF (Nebulizer (Direct Patient Interface)). FDA records list 16 510(k) clearances for Promedic, Inc., from to . As of , FDA records show no recalls naming K060497.

Clearance record

Decision date
Received
(137 days to decision)
Product code
CAF Nebulizer (Direct Patient Interface)
Regulation
21 CFR 868.5630
Device class
Class II
Review panel
Anesthesiology
Applicant
Promedic, Inc. 3460 Pt.e Creek Ct. #102, Bonita Springs FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code CAF

Trailing 12 months
4 clearances under product code CAF in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CAF, trailing twelve months
MonthClearances
November 20251
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20261
October 20260