Cleared Traditional

K925822 - CUSTOM SYRIGENE KITS

K925822 is an FDA 510(k) clearance for CUSTOM SYRIGENE KITS, manufactured by Syrigene Medical Technologies, Inc.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 521-day FDA review.

K925822 · Syrigene Medical Technologies, Inc. · General Hospital
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Apr 1994
Decision
521d
Days
Class 2
Risk

K925822 is an FDA 510(k) clearance for the CUSTOM SYRIGENE KITS. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Syrigene Medical Technologies, Inc. (Palm Florida, US). The FDA issued a Cleared decision on April 22, 1994 after a review of 521 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Syrigene Medical Technologies, Inc. devices

FDA 510(k) Submission Details - K925822

510(k) Number K925822 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1992
Decision Date April 22, 1994
Days to Decision 521 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
392d slower than avg
Panel avg: 129d · This submission: 521d
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 535
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K925822.
1ML LUER-LOK SYRINGE
K941562 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1994
BD MICRO FINE, ULTRA FINE, AND ALLERGY SYRINGE
K941657 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1994
ADVANTAGE SYRINGE
K941545 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1994
RIVER VIAL ADAPTER
K933335 · River Medical, Inc. · Mar 1994
ONE TIME VIAL ACCESS SPIKE
K934561 · Icu Medical, Inc. · Feb 1994
SPRING LOADED SYRINGE
K931095 · Acacia, Inc. · Sep 1993