Cleared Traditional

K884154 - TRANSLUMINAL ENDARTERECTOMY DEVICE

K884154 is an FDA 510(k) clearance for TRANSLUMINAL ENDARTERECTOMY DEVICE, manufactured by Thomas J. Fogarty, M.D.. The device is a Class 2 Gastroenterology & Urology device with product code LIF cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K884154 · Thomas J. Fogarty, M.D. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1988
Decision
85d
Days
Class 2
Risk

K884154 is an FDA 510(k) clearance for the TRANSLUMINAL ENDARTERECTOMY DEVICE. Classified as Dialyzer Reprocessing System (product code LIF), Class II - Special Controls.

Submitted by Thomas J. Fogarty, M.D. (Palo Alto, US). The FDA issued a Cleared decision on December 27, 1988 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5820 - the FDA gastroenterology and urology 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Thomas J. Fogarty, M.D. devices

FDA 510(k) Submission Details - K884154

510(k) Number K884154 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 1988
Decision Date December 27, 1988
Days to Decision 85 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 131d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LIF Device Classification - Class 2, Special Controls

Product Code LIF Dialyzer Reprocessing System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5820
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - LIF Dialyzer Reprocessing System

All 33
Devices cleared under the same product code (LIF) and FDA review panel - the closest regulatory comparables to K884154.
SERIM GLUTARALDEHYDE/NEPHREX POTENCY TEST KIT
K902227 · Serim Research Corp. · Apr 1991
RENATRON II DIALYZER REPROCESSING SYSTEM RS 8330
K904210 · Minntech Corp. · Nov 1990
SERIM RESIDUAL PEROXIDE/RENALIN TEST KIT
K900341 · Serim Research Corp. · Jul 1990
FRESENIUS PURISTERIL 340 (TM)
K874573 · Seratronics, Inc. · Apr 1988
ADR-22 AUTOMATIC DIALYZER REPROCESSOR
K874034 · Biodynamics Corp. · Oct 1987
DRS-4 DIALYZER REPROCESSING SYSTEM
K860674 · Seratronics, Inc. · Apr 1986