Cleared Traditional

K902729 - R.P.I. GRAVITY SAFE FEEDING BAG

K902729 is an FDA 510(k) clearance for R.P.I. GRAVITY SAFE FEEDING BAG, manufactured by Ridge Products, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K902729 · Ridge Products, Inc. · Gastroenterology & Urology device
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Aug 1990
Decision
48d
Days
Class 2
Risk

K902729 is an FDA 510(k) clearance for the R.P.I. GRAVITY SAFE FEEDING BAG. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Ridge Products, Inc. (Lakewood, US). The FDA issued a Cleared decision on August 8, 1990 after a review of 48 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 Ridge Products, Inc. devices

FDA 510(k) Submission Details - K902729

510(k) Number K902729 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 1990
Decision Date August 08, 1990
Days to Decision 48 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
82d faster than avg
Panel avg: 130d · This submission: 48d
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 302
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K902729.
ENTERAL PUMP SET WITH ENTERAL SPIKE
K895142 · Delmed, Inc. · Oct 1990
600ML AND 1200ML ENTERAL BAG ADM. SET FOR ENTERA
K895329 · Delmed, Inc. · Oct 1990
ENTERAL PUMP SET W/ENTERA-FLO SPIKE
K895650 · Delmed, Inc. · Oct 1990
DOBBHOFF WIRE GUIDED JEJUNAL FEEDING TUBE
K900324 · Biosearch Medical Products, Inc. · Aug 1990
DOBBHOFF(R) ENDOENTERIC GASTRIC DECOMPRESSION CATH
K900563 · Biosearch Medical Products, Inc. · Aug 1990
BIOSEARCH DOBBHOFF(R) GASTROTRAC JEJUNAL FEEDING
K900590 · Biosearch Medical Products, Inc. · Aug 1990