Cleared Traditional

K913541 - NEO-THOR THORACOSTOMY KIT

K913541 is the FDA 510(k) clearance for NEO-THOR THORACOSTOMY KIT by Intl. Medical Devices , Ltd.. It is a Class 2 General Hospital device (product code FMF) cleared through the Traditional 510(k) pathway after a 244-day FDA review.

K913541 · Intl. Medical Devices , Ltd. · General Hospital
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Apr 1992
Decision
244d
Days
Class 2
Risk

K913541 is an FDA 510(k) clearance for the NEO-THOR THORACOSTOMY KIT. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Intl. Medical Devices , Ltd. (Los Angeles, US). The FDA issued a Cleared decision on April 9, 1992 after a review of 244 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 Intl. Medical Devices , Ltd. devices

Submission Details

510(k) Number K913541 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 1991
Decision Date April 09, 1992
Days to Decision 244 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
115d slower than avg
Panel avg: 129d · This submission: 244d
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 254
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K913541.
IRRIGATING SYRINGE
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B-D INTERLINK SYRINGE CANNULA
K920422 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1992
BECTON DICKINSON SAFETY-LOK SYRINGE
K920321 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1992
B-D(TM) MICROFINE(TM) IV PEN INJECTOR CAT. #328204
K912330 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1991
NEEDLE*LESS DRUG VIAL ADAPTER
K894177 · Baxter Healthcare Corp · Sep 1989
DISPENSING PIN/CHEMOTHERAPY DISPENSING PIN
K890082 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1989