Cleared Traditional

NHMC IRRIGATION TRAY (K962670) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K962670 · National Healthcare Mfg. Corp. · Gastroenterology & Urology device
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Aug 1996
Decision
36d
Days
Class 2
Risk

K962670 is an FDA 510(k) clearance for the NHMC IRRIGATION TRAY. Classified as System, Irrigation, Urological (product code LJH), Class II - Special Controls.

Submitted by National Healthcare Mfg. Corp. (Winnipeg, Mb, CA). The FDA issued a Cleared decision on August 14, 1996 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - 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 National Healthcare Mfg. Corp. devices

Submission Details

510(k) Number K962670 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 1996
Decision Date August 14, 1996
Days to Decision 36 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 130d · This submission: 36d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LJH System, Irrigation, Urological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5130
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 - LJH System, Irrigation, Urological

All 27
Devices cleared under the same product code (LJH) and FDA review panel - the closest regulatory comparables to K962670.
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KSEA UROPUMP
K981615 · KARL STORZ Endoscopy-America, Inc. · Jul 1998
KARL STORZ MODEL 203020 20 EQUIMAT
K971982 · KARL STORZ Endoscopy-America, Inc. · Aug 1997
MEDLINE Y-TYPE TUR/BLADDER IRRIGATION SET
K970946 · Medline Industries, Inc. · Jun 1997
TUR,ARTHROSCOPIC,CYSTOSCOPY IRRIGATION SETS
K960787 · Baxter Healthcare Corp · May 1996
KSEA DISPOSABLE TUBING SET FOR THE UROMAT PUMP
K945210 · KARL STORZ Endoscopy-America, Inc. · Feb 1995