Cleared Traditional

K921415 - IRRIGATION TUBING SET

K921415 is an FDA 510(k) clearance for IRRIGATION TUBING SET, manufactured by Psi Medical Products, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KOD cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K921415 · Psi Medical Products, Inc. · Gastroenterology & Urology device
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Sep 1992
Decision
164d
Days
Class 2
Risk

K921415 is an FDA 510(k) clearance for the IRRIGATION TUBING SET. Classified as Catheter, Urological (product code KOD), Class II - Special Controls.

Submitted by Psi Medical Products, Inc. (Norwalk, US). The FDA issued a Cleared decision on September 4, 1992 after a review of 164 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 Psi Medical Products, Inc. devices

FDA 510(k) Submission Details - K921415

510(k) Number K921415 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1992
Decision Date September 04, 1992
Days to Decision 164 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
34d slower than avg
Panel avg: 130d · This submission: 164d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KOD Device Classification - Class 2, Special Controls

Product Code KOD Catheter, 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 - KOD Catheter, Urological

All 130
Devices cleared under the same product code (KOD) and FDA review panel - the closest regulatory comparables to K921415.
BARD LATEX URINARY CATHETERS
K922431 · C.R. Bard, Inc. · Mar 1993
RADIFOCUS GUIDE WIRE M
K923607 · Terumo Medical Corp. · Oct 1992
KENDALL MOD. PEDIATRIC ULTRAMER POLYURETHANE CATH.
K921054 · Kendall Healthcare Products Co. Div.Of Tyco Health · Sep 1992
NAUDE URETHRAL STENT
K912851 · Cook Urological, Inc. · Jan 1992
KENDALL PEDIATRIC ULTRAMER POLYURETHANE CATHETER
K911242 · Kendall Healthcare Products Co. Div.Of Tyco Health · Apr 1991
PHARMASEAL DISPOSABLE ABDOMINAL TROCAR
K904734 · Baxter Healthcare Corp · Nov 1990