Cleared Traditional

K942394 - SAFE VENT SYSTEM

K942394 is an FDA 510(k) clearance for SAFE VENT SYSTEM, manufactured by Incutech, Inc.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 253-day FDA review.

K942394 · Incutech, Inc. · General Hospital
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Jan 1995
Decision
253d
Days
Class 2
Risk

K942394 is an FDA 510(k) clearance for the SAFE VENT SYSTEM. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Incutech, Inc. (Greensboro, US). The FDA issued a Cleared decision on January 27, 1995 after a review of 253 days - an extended review cycle.

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.

FDA 510(k) Submission Details - K942394

510(k) Number K942394 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 1994
Decision Date January 27, 1995
Days to Decision 253 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
124d slower than avg
Panel avg: 129d · This submission: 253d
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 686
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K942394.
MONOJECT(R) PISTON SYRINGES
K945715 · Sherwood Medical Co. · Mar 1995
DISPOSABLE 1CC SYRINGE WITH LUER LOCK
K945588 · Interventional Therapeutics Corp. · Feb 1995
SAFE-1(TM) SYRINGE
K940635 · Safety 1st Medical, Inc. · Jan 1995
DISPOSABLE SYRINGES AND DISPOSABLE NEEDLES
K945225 · Myco Medical Supplies, Inc. · Jan 1995
CG DISPOSABLE SYRINGE
K944920 · Fortunique Medical Products · Dec 1994
DISPOSABLE DISC FILTER
K936015 · Medi-Dose, Inc. · Dec 1994
K942394 · SAFE VENT SYSTEM
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