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
K973238Substantially Equivalent

Zefon Adult Anesthesia Breathing Circuit with Filter, Zefon Pediatric Anesthesia Breathing Circuit with Filter

Bill Olson Corp., Ocala FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K973238 is the FDA 510(k) clearance record for ZEFON ADULT ANESTHESIA BREATHING CIRCUIT WITH FILTER, ZEFON PEDIATRIC ANESTHESIA BREATHING CIRCUIT WITH FILTER, a class II device, cleared for Bill Olson Corp. on under FDA product code CAH (Filter, Bacterial, Breathing-Circuit). FDA records list 4 510(k) clearances for Bill Olson Corp., from to . As of , FDA records show no recalls naming K973238.

Clearance record

Decision date
Received
(195 days to decision)
Product code
CAH Filter, Bacterial, Breathing-Circuit
Regulation
21 CFR 868.5260
Device class
Class II
Review panel
Anesthesiology
Applicant
Bill Olson Corp. 5350 SW First Ln., Ocala FL
510(k) summary
Statement
Third party review
No

Clearances, product code CAH

Trailing 12 months
2 clearances under product code CAH in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CAH, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260