Cleared Traditional

K945410 - IRT LOCKING SYRINGE

K945410 is an FDA 510(k) clearance for IRT LOCKING SYRINGE, manufactured by Interventional Research Technologies. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 777-day FDA review.

K945410 · Interventional Research Technologies · General Hospital
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Dec 1996
Decision
777d
Days
Class 2
Risk

K945410 is an FDA 510(k) clearance for the IRT LOCKING SYRINGE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Interventional Research Technologies (Miami, US). The FDA issued a Cleared decision on December 19, 1996 after a review of 777 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 Interventional Research Technologies devices

FDA 510(k) Submission Details - K945410

510(k) Number K945410 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1994
Decision Date December 19, 1996
Days to Decision 777 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
648d slower than avg
Panel avg: 129d · This submission: 777d
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 389
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K945410.
RAMY PISTON SYRINGE
K971664 · Alshifa Medical Syringes Mfg. Co., Ltd. · Jul 1997
RAMY INTEGRATED NEEDLE SYRINGE
K972452 · Alshifa Medical Syringes Mfg. Co., Ltd. · Jul 1997
BRANNON ARTERIO-VENOUS PORTSYRINGE
K965030 · Vascular Logics, Inc. · Mar 1997
DRESSING CHANGE TRAYS
K963260 · Busse Hospital Disposables, Inc. · Nov 1996
TERUMO RETRACTABLE NEEDLE (RN) SYRINGE
K953940 · Terumo Medical Corp. · May 1996
THERMOGENESIS DROP APPLICATOR, KITS, SPRAY KITS AND TIPS
K955282 · Thermogenesis Corp. · May 1996