Cleared Traditional

K890116 - ENTERAL FEEDING TUBE

K890116 is an FDA 510(k) clearance for ENTERAL FEEDING TUBE, manufactured by Hdc Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FPD cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K890116 · Hdc Corp. · Gastroenterology & Urology device
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Apr 1989
Decision
84d
Days
Class 2
Risk

K890116 is an FDA 510(k) clearance for the ENTERAL FEEDING TUBE. Classified as Tube, Feeding (product code FPD), Class II - Special Controls.

Submitted by Hdc Corp. (Mountain View, US). The FDA issued a Cleared decision on April 5, 1989 after a review of 84 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Hdc Corp. devices

FDA 510(k) Submission Details - K890116

510(k) Number K890116 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1989
Decision Date April 05, 1989
Days to Decision 84 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
46d faster than avg
Panel avg: 130d · This submission: 84d
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 K890116.
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
KENDALL CURITY FEEDING TUBES
K892431 · The Kendal Co. · May 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