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
K853828Substantially Equivalent

Fls Med. Prod. Racine Type Adaptor

Fls Medical Products, Inc., Pinellas Park FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K853828 is the FDA 510(k) clearance record for FLS MED. PROD. RACINE TYPE ADAPTOR, a class I device, cleared for Fls Medical Products, Inc. on under FDA product code BZA (Connector, Airway (Extension)). FDA records list 2 510(k) clearances for Fls Medical Products, Inc., from to . As of , FDA records show no recalls naming K853828.

Clearance record

Decision date
Received
(46 days to decision)
Product code
BZA Connector, Airway (Extension)
Regulation
21 CFR 868.5810
Device class
Class I
Review panel
Anesthesiology
Applicant
Fls Medical Products, Inc. 5081 69th. Ave. N., Pinellas Park FL
Third party review
No

Clearances, product code BZA

Trailing 12 months

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

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