Cleared Traditional

K142767 - ThinkMed Intermittent Catheter with/without Hydrophilic Coating

K142767 is an FDA 510(k) clearance for ThinkMed Intermittent Catheter with/wit..., manufactured by Thinkmed Medical Technology Co., Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code GBM cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K142767 · Thinkmed Medical Technology Co., Ltd. · Gastroenterology & Urology device
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Feb 2015
Decision
131d
Days
Class 2
Risk

K142767 is an FDA 510(k) clearance for the ThinkMed Intermittent Catheter with/without Hydrophilic Coating. Classified as Catheter, Urethral (product code GBM), Class II - Special Controls.

Submitted by Thinkmed Medical Technology Co., Ltd. (Kunshan, CN). The FDA issued a Cleared decision on February 3, 2015 after a review of 131 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 Thinkmed Medical Technology Co., Ltd. devices

FDA 510(k) Submission Details - K142767

510(k) Number K142767 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2014
Decision Date February 03, 2015
Days to Decision 131 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 131d · This submission: 131d
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 65
Devices cleared under the same product code (GBM) and FDA review panel - the closest regulatory comparables to K142767.
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K141642 · Hollister Incorporated · Aug 2014