Cleared Traditional

K875171 - J-CATH(TM)

K875171 is an FDA 510(k) clearance for J-CATH(TM), manufactured by Hdc Corp.. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K875171 · Hdc Corp. · Gastroenterology & Urology device
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Apr 1988
Decision
111d
Days
Class 2
Risk

K875171 is an FDA 510(k) clearance for the J-CATH(TM). Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Hdc Corp. (Mountain View, US). The FDA issued a Cleared decision on April 6, 1988 after a review of 111 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5980 - 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 Hdc Corp. devices

FDA 510(k) Submission Details - K875171

510(k) Number K875171 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 1987
Decision Date April 06, 1988
Days to Decision 111 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 130d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNT Device Classification - Class 2, Special Controls

Product Code KNT Tubes, Gastrointestinal (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5980
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 - KNT Tubes, Gastrointestinal (and Accessories)

All 344
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K875171.
MIC (SPECIFIC LINE) REPLACEMENT KIT
K880768 · Medical Innovations Corp. · Apr 1988
MEDSURG PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TRAY
K874936 · Medsurg Industries, Inc. · Apr 1988
ENTERAL BAG/SET
K880051 · Churchill Corp. · Apr 1988
ENTERON PERCUTAN. ENDOSCOPIC GASTROSTOMY TRAY-PEG
K873360 · Endovations · Mar 1988
NH REPLACEMENT GASTROSTOMY KIT
K880232 · Biosearch Medical Products, Inc. · Mar 1988
MIC (SPECIFIC LINE) INSERTION KIT
K875126 · Medical Innovations Corp. · Mar 1988