Cleared Traditional

K942394 - SAFE VENT SYSTEM

K942394 is the FDA 510(k) clearance for SAFE VENT SYSTEM by Incutech, Inc.. It is a Class 2 General Hospital device (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.

View all Incutech, Inc. devices

Submission Details

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

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.

Device Classification

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 250

Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K942394.

PTFE SYRINGE FILTER

K952918 · B.Braun Medical, Inc. · Sep 1995

STRYKER DROP APPLICATOR, KITS, SPRAY APPLICATOR KIT, TIPS

K950824 · Stryker Corp. · Aug 1995

MONOJECT(R) PISTON SYRINGES

K945715 · Sherwood Medical Co. · Mar 1995

SYRINGE

K942615 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1994

MEDSAVER SYRINGE

K941095 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1994

1ML LUER-LOK SYRINGE

K941562 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1994

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K942394

Incutech, Inc.

Greensboro, NC · US

ROGER V MOLINA

Regulatory profile

5 submissions 4 cleared

80% clearance rate · Active in General Hospital

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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