510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K883227Substantially Equivalent

Skifa, Plastic Disposable Syringe

P.T. Setio Harto, Ltd., Rancho CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K883227 is the FDA 510(k) clearance record for SKIFA, PLASTIC DISPOSABLE SYRINGE, a class II device, cleared for P.T. Setio Harto , Ltd. on under FDA product code FMF (Syringe, Piston). FDA records list one 510(k) clearance for P.T. Setio Harto , Ltd. As of , FDA records show no recalls naming K883227.

Clearance record

Decision date
Received
(59 days to decision)
Product code
FMF Syringe, Piston
Regulation
21 CFR 880.5860
Device class
Class II
Review panel
General Hospital
Applicant
P.T. Setio Harto , Ltd. Frank Strausser, Rancho CA
Third party review
No

Clearances, product code FMF

Trailing 12 months
14 clearances under product code FMF in the twelve months to October 2026, December 2025 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code FMF, trailing twelve months
MonthClearances
November 20251
December 20254
January 20260
February 20261
March 20260
April 20261
May 20261
June 20262
July 20261
August 20263
September 20260
October 20260