Cleared Traditional

K101900 - HAKKI URINARY CATHETER

Also marketed or referenced as:
SIZE 14, 16, 18, 20, 22, 24, 26 FRENCH

K101900 is an FDA 510(k) clearance for HAKKI URINARY CATHETER, manufactured by Hakki Medical Technologies, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code GBM cleared through the Traditional 510(k) pathway after a 215-day FDA review.

K101900 · Hakki Medical Technologies, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2011
Decision
215d
Days
Class 2
Risk

K101900 is an FDA 510(k) clearance for the HAKKI URINARY CATHETER. Classified as Catheter, Urethral (product code GBM), Class II - Special Controls.

Submitted by Hakki Medical Technologies, Inc. (Pinellas Park, US). The FDA issued a Cleared decision on February 7, 2011 after a review of 215 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 Hakki Medical Technologies, Inc. devices

FDA 510(k) Submission Details - K101900

510(k) Number K101900 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2010
Decision Date February 07, 2011
Days to Decision 215 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d slower than avg
Panel avg: 131d · This submission: 215d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GBM Device Classification - Class 2, Special Controls

Product Code GBM Catheter, Urethral
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 - GBM Catheter, Urethral

All 61
Devices cleared under the same product code (GBM) and FDA review panel - the closest regulatory comparables to K101900.
SPEEDICATH COMPACT SET (12/18 FR)
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BEVER UNOCATED / COATED, PAEDIATRIC / MALE / FEMALE NELATON-TIP / TIEMANN-TIP INTERMITTENT CATHETER,
K111405 · Hangzhou Bever Medical Devices Co., Ltd. · Feb 2012
VAPRO PLUS INTERMITTENT CATHETER
K110862 · Hollister Incorporated · Apr 2011
VAPRO INTERMITTENT CATHETER, MODEL 72062, 72082,72102, 72122, 72142, 72064, 72084, 72104, 72124,72144, 72164, 72184,
K090960 · Hollister, Inc. · Aug 2009
SPEEDICATH COMPACT
K072808 · Coloplast Corp. · Nov 2007
ASTRA TECH AB LOFRIC PRIMO SINGLE USE URINARY CATHETER
K050874 · Astra Tech, Inc. · May 2005