510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K002569Substantially Equivalent

Glucosource Insulin Syringes and Malgam Single-Use Insulin and Single Use Hypodermic Syringes

Malgam Ent., Inc., San Francisco CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K002569 is the FDA 510(k) clearance record for GLUCOSOURCE INSULIN SYRINGES AND MALGAM SINGLE-USE INSULIN AND SINGLE USE HYPODERMIC SYRINGES, a class II device, cleared for Malgam Ent., Inc. on under FDA product code FMF (Syringe, Piston). FDA records list one 510(k) clearance for Malgam Ent., Inc. As of , FDA records show no recalls naming K002569.

Clearance record

Decision date
Received
(116 days to decision)
Product code
FMF Syringe, Piston
Regulation
21 CFR 880.5860
Device class
Class II
Review panel
General Hospital
Applicant
Malgam Ent., Inc. 2 Clarence Pl., #12, San Francisco CA
510(k) summary
Summary
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