Cleared Traditional

K902091 - SCHNEIDER MONORAIL(TM) SOFTRAC-PTA(TM) ...

K902091 is an FDA 510(k) clearance for SCHNEIDER MONORAIL(TM) SOFTRAC-PTA(TM) ..., manufactured by Schneider Intl., Ltd.. The device is a Class 2 Cardiovascular device with product code LIT cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K902091 · Schneider Intl., Ltd. · Cardiovascular device
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Sep 1990
Decision
140d
Days
Class 2
Risk

K902091 is an FDA 510(k) clearance for the SCHNEIDER MONORAIL(TM) SOFTRAC-PTA(TM) CATHETER. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Schneider Intl., Ltd. (Plymouth, US). The FDA issued a Cleared decision on September 26, 1990 after a review of 140 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - the FDA cardiovascular device oversight 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Schneider Intl., Ltd. devices

FDA 510(k) Submission Details - K902091

510(k) Number K902091 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1990
Decision Date September 26, 1990
Days to Decision 140 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 125d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LIT Device Classification - Class 2, Special Controls

Product Code LIT Catheter, Angioplasty, Peripheral, Transluminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - LIT Catheter, Angioplasty, Peripheral, Transluminal

All 262
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K902091.
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GUIDEWIRE TORQUE DEVICE AND GUIDEWIRE INTRODUCER
K903606 · North American Instrument Corp. · Sep 1990
SMALL VESSEL BALLOON DILATATION CATHETER
K897124 · Boston Scientific Corp · Jul 1990
MODIFIED TRANSLUMINAL BALLOON DILATATION CATHETERS
K901018 · Boston Scientific Corp · May 1990
LE PTA CATHETER
K894250 · Baxter Healthcare Corp · Mar 1990