Cleared Traditional

K905677 - JEJUNO-CATH KIT

K905677 is an FDA 510(k) clearance for JEJUNO-CATH KIT, manufactured by Health Improvement Assoc.. The device is a Class 2 Gastroenterology & Urology device with product code FPD cleared through the Traditional 510(k) pathway after a 233-day FDA review.

K905677 · Health Improvement Assoc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1991
Decision
233d
Days
Class 2
Risk

K905677 is an FDA 510(k) clearance for the JEJUNO-CATH KIT. Classified as Tube, Feeding (product code FPD), Class II - Special Controls.

Submitted by Health Improvement Assoc. (Freeland, US). The FDA issued a Cleared decision on August 9, 1991 after a review of 233 days - an extended review cycle.

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 Health Improvement Assoc. devices

FDA 510(k) Submission Details - K905677

510(k) Number K905677 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 1990
Decision Date August 09, 1991
Days to Decision 233 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
102d slower than avg
Panel avg: 131d · This submission: 233d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPD Device Classification - Class 2, Special Controls

Product Code FPD Tube, Feeding
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 - FPD Tube, Feeding

All 44
Devices cleared under the same product code (FPD) and FDA review panel - the closest regulatory comparables to K905677.
STOMA MEASURING DEVICE
K914482 · Biosearch Medical Products, Inc. · Dec 1991
EXTERNAL GASTROSTOMY TUBE RETAINER
K912575 · Sandoz Nutrition · Nov 1991
FLEXIFLO OVER THE GUIDEWIRE JEJUNAL FEEDING TUBE
K912972 · Abbott Laboratories · Sep 1991
WILSON-COOK PULL THROUGH PEG KIT
K901163 · Wilson-Cook Medical, Inc. · Nov 1990
INFANT FEEDING TUBE
K896559 · Westmark, Sterile Packing Systems, Inc. (Sps) · Mar 1990
WILTEK GASTRIC FEEDING TUBE
K894860 · Wiltek Medical, Inc. · Dec 1989