Cleared Traditional

K770620 - TUBING FEEDING KIT

K770620 is the FDA 510(k) clearance for TUBING FEEDING KIT by Doyle Pharmaceutical. It is a Class 2 Gastroenterology & Urology device (product code FPD) cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K770620 · Doyle Pharmaceutical · Gastroenterology & Urology device
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May 1977
Decision
32d
Days
Class 2
Risk

K770620 is an FDA 510(k) clearance for the TUBING FEEDING KIT. Classified as Tube, Feeding (product code FPD), Class II - Special Controls.

Submitted by Doyle Pharmaceutical (Mchenry, US). The FDA issued a Cleared decision on May 3, 1977 after a review of 32 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 Doyle Pharmaceutical devices

Submission Details

510(k) Number K770620 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1977
Decision Date May 03, 1977
Days to Decision 32 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
98d faster than avg
Panel avg: 130d · This submission: 32d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.