Cleared Traditional

K862090 - MCGAW NUTRA-FEED EFS ENTERAL FEEDING BAG

K862090 is an FDA 510(k) clearance for MCGAW NUTRA-FEED EFS ENTERAL FEEDING BAG, manufactured by Kendall Mcgaw Laboratories, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FPD cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K862090 · Kendall Mcgaw Laboratories, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1986
Decision
123d
Days
Class 2
Risk

K862090 is an FDA 510(k) clearance for the MCGAW NUTRA-FEED EFS ENTERAL FEEDING BAG. Classified as Tube, Feeding (product code FPD), Class II - Special Controls.

Submitted by Kendall Mcgaw Laboratories, Inc. (Santa Ana, US). The FDA issued a Cleared decision on October 3, 1986 after a review of 123 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 Kendall Mcgaw Laboratories, Inc. devices

FDA 510(k) Submission Details - K862090

510(k) Number K862090 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1986
Decision Date October 03, 1986
Days to Decision 123 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
7d faster than avg
Panel avg: 130d · This submission: 123d
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 20
Devices cleared under the same product code (FPD) and FDA review panel - the closest regulatory comparables to K862090.
INFANT FEEDING TUBE
K896559 · Westmark, Sterile Packing Systems, Inc. (Sps) · Mar 1990
KENDALL CURITY FEEDING TUBES
K892431 · The Kendal Co. · May 1989
ENTERAL FEEDING TUBE
K890116 · Hdc Corp. · Apr 1989
ADMINISTRATION SET
K810131 · G.D. Searle and Co. · Feb 1981
DOBBHOFF ENTERIC FEEDING BAG
K781385 · Biosearch Medical Products, Inc. · Sep 1978
TUBE, FEEDING, ARGYLE
K760137 · Sherwood Medical Industries · Jul 1976