Cleared Traditional

K923497 - FLUSHING IRRIGATION SET

K923497 is an FDA 510(k) clearance for FLUSHING IRRIGATION SET, manufactured by Orion Life Systems, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KDH cleared through the Traditional 510(k) pathway after a 614-day FDA review.

K923497 · Orion Life Systems, Inc. · Gastroenterology & Urology device
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Mar 1994
Decision
614d
Days
Class 2
Risk

K923497 is an FDA 510(k) clearance for the FLUSHING IRRIGATION SET. Classified as Catheter (gastric, Colonic, Etc.), Irrigation And Aspiration (product code KDH), Class II - Special Controls.

Submitted by Orion Life Systems, Inc. (Wheeling, US). The FDA issued a Cleared decision on March 21, 1994 after a review of 614 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5980 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Orion Life Systems, Inc. devices

FDA 510(k) Submission Details - K923497

510(k) Number K923497 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received July 15, 1992
Decision Date March 21, 1994
Days to Decision 614 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
483d slower than avg
Panel avg: 131d · This submission: 614d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KDH Device Classification - Class 2, Special Controls

Product Code KDH Catheter (gastric, Colonic, Etc.), Irrigation And Aspiration
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5980
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 - KDH Catheter (gastric, Colonic, Etc.), Irrigation And Aspiration

All 8
Devices cleared under the same product code (KDH) and FDA review panel - the closest regulatory comparables to K923497.
COMBIPORT FLUID LAVAGE DEVICE
K971259 · B.Braun Medical, Inc. · Oct 1997
TUM-E-VAC
K962850 · Ethox Corp. · Feb 1997
EASI-LAV PEDIATRIC / ADULT GASTRIC LAVAGE KIT
K951533 · Ballard Medical Products · Jul 1995
HEMORRHOIDAL LIGATOR WITH SUCTION
K900086 · Baxter Healthcare Corp · Mar 1990
ETHOX LAVAGE TUBE
K860599 · Ethox Corp. · Mar 1986
TUBING, AXIOM SILICONE PENROSE
K781749 · Axiom Medical, Inc. · Dec 1978