510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K852996Substantially Equivalent

Dyna Gard Syringe Filter

Microgon, Inc., Laguna Hills CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K852996 is the FDA 510(k) clearance record for DYNA GARD SYRINGE FILTER, a class II device, cleared for Microgon, Inc. on under FDA product code FPB (Filter, Infusion Line). FDA records list one 510(k) clearance for Microgon, Inc. As of , FDA records show no recalls naming K852996.

Clearance record

Decision date
Received
(66 days to decision)
Product code
FPB Filter, Infusion Line
Regulation
21 CFR 880.5440
Device class
Class II
Review panel
General Hospital
Applicant
Microgon, Inc. 23152 Verdugo Dr., Laguna Hills CA
Third party review
No

Clearances, product code FPB

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