Cleared Traditional

K031457 - ENDOMAT LC PUMP

K031457 is the FDA 510(k) clearance for ENDOMAT LC PUMP by KARL STORZ Endoscopy-America, Inc.. It is a Class 2 Gastroenterology & Urology device (product code OCX) cleared through the Traditional 510(k) pathway after a 356-day FDA review.

K031457 · KARL STORZ Endoscopy-America, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2004
Decision
356d
Days
Class 2
Risk

K031457 is an FDA 510(k) clearance for the ENDOMAT LC PUMP, MODEL 20 3303 20. Classified as Endoscopic Irrigation/suction System (product code OCX), Class II - Special Controls.

Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on April 28, 2004 after a review of 356 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all KARL STORZ Endoscopy-America, Inc. devices

Submission Details

510(k) Number K031457 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 2003
Decision Date April 28, 2004
Days to Decision 356 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
226d slower than avg
Panel avg: 130d · This submission: 356d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OCX Endoscopic Irrigation/suction System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Supply Sterile Water, Other Solutions And/or Suction To Endoscopes During Endoscopic Procedures.
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 - OCX Endoscopic Irrigation/suction System

All 58
Devices cleared under the same product code (OCX) and FDA review panel - the closest regulatory comparables to K031457.
IRRIGATION SYSTEM
K103239 · United States Endoscopy Group, Inc. · Dec 2010
ERBEFLO 2 DISPOSABLE TUBING SYSTEM
K103235 · Erbe USA, Inc. · Dec 2010
IRRIGATION PUMP, IRRIGATION BIOPSY VALVE, ,MODEL 00711520, 00711139, 00711140
K092461 · United States Endoscopy Group, Inc. · Nov 2009
KSEA QUADRO SWITCH
K021776 · Karl Storz Endoscopy · Aug 2002
HYDROTOWER MANAGEMENT SYSTEM, MODEL 4-750-00
K993778 · Northgate Technologies, Inc. · Jan 2000
CONTINUOUS FLOW SYSTEM, CFS-1 PUMP SYSTEM (4-700-00)
K964196 · Northgate Technologies, Inc. · Dec 1996