Cleared Traditional

K002569 - GLUCOSOURCE INSULIN SYRINGES AND MALGAM SINGLE-USE INSULIN AND SINGLE USE HYPODERMIC SYRINGES

K002569 is an FDA 510(k) clearance for GLUCOSOURCE INSULIN SYRINGES AND MALGAM..., manufactured by Malgam Ent., Inc.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K002569 · Malgam Ent., Inc. · General Hospital
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Optimized for regulatory review, auditing and printing
Dec 2000
Decision
116d
Days
Class 2
Risk

K002569 is an FDA 510(k) clearance for the GLUCOSOURCE INSULIN SYRINGES AND MALGAM SINGLE-USE INSULIN AND SINGLE USE HYP.... Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Malgam Ent., Inc. (San Francisco, US). The FDA issued a Cleared decision on December 12, 2000 after a review of 116 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Malgam Ent., Inc. devices

FDA 510(k) Submission Details - K002569

510(k) Number K002569 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 2000
Decision Date December 12, 2000
Days to Decision 116 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 129d · This submission: 116d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMF Device Classification - Class 2, Special Controls

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FMF Syringe, Piston

All 478
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K002569.
SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE
K003571 · Terumo Medical Corp. · Feb 2001
STERILE PISTON SYRINGE
K002717 · Abbott Laboratories · Jan 2001
INJECTRITE-C15 AND INJECTRITE-C30
K002127 · Sterling Medivations, Inc. · Dec 2000
DUPLOGRIP
K003193 · Baxter Healthcare Corp · Nov 2000
TISSOMAT AND SPRAY SET
K981089 · Baxter Healthcare Corp · Jul 2000
TERUMO U-100 INSULIN SYRING
K001474 · Terumo Medical Corp. · Jun 2000