510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K940220Substantially Equivalent

Rebreather Bags

Zefon Medical Products, Ocala FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K940220 is the FDA 510(k) clearance record for REBREATHER BAGS, a class I device, cleared for Zefon Medical Products on under FDA product code BTC (Bag, Reservoir). FDA records list 4 510(k) clearances for Zefon Medical Products, from to . As of , FDA records show no recalls naming K940220.

Clearance record

Decision date
Received
(126 days to decision)
Product code
BTC Bag, Reservoir
Regulation
21 CFR 868.5320
Device class
Class I
Review panel
Anesthesiology
Applicant
Zefon Medical Products 5350 Southwest First Ln., Ocala FL
510(k) summary
Summary
Third party review
No

Clearances, product code BTC

Trailing 12 months

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

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