Cleared Traditional

K893390 - MODIFIED PRISTINE CULTURE CATHETER

K893390 is an FDA 510(k) clearance for MODIFIED PRISTINE CULTURE CATHETER, manufactured by Hml Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KOD cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K893390 · Hml Medical, Inc. · Gastroenterology & Urology device
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Sep 1989
Decision
129d
Days
Class 2
Risk

K893390 is an FDA 510(k) clearance for the MODIFIED PRISTINE CULTURE CATHETER. Classified as Catheter, Urological (product code KOD), Class II - Special Controls.

Submitted by Hml Medical, Inc. (Irvine, US). The FDA issued a Cleared decision on September 7, 1989 after a review of 129 days - within the typical 510(k) review window.

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 Hml Medical, Inc. devices

FDA 510(k) Submission Details - K893390

510(k) Number K893390 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1989
Decision Date September 07, 1989
Days to Decision 129 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
1d faster than avg
Panel avg: 130d · This submission: 129d
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 K893390.
CYSTO PUMP DRAINAGE BAG
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CYSTOSCOPY/IRRIGATION SET
K896211 · Westmark, Sterile Packing Systems, Inc. (Sps) · Jan 1990
Y-TYPE TUR/CONTINUOUS BLADDER IRRIGATION SET
K896213 · Westmark, Sterile Packing Systems, Inc. (Sps) · Jan 1990
KENDALL CURITY IRRIGATION SYRINGE
K892436 · The Kendal Co. · Jul 1989
CATHETERS, MALE, FEMALE
K892691 · Zinnanti Surgical Instruments, Inc. · Jun 1989
CATHETER STRAP
K881781 · Baxter Healthcare Corp · Aug 1988