Cleared Traditional

FLEXIFLO COMPANION ENTERAL PUMP SETS AND CONTAINER (K921697) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K921697 · Abbott Laboratories · Gastroenterology & Urology device
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Aug 1992
Decision
139d
Days
Class 2
Risk

K921697 is an FDA 510(k) clearance for the FLEXIFLO COMPANION ENTERAL PUMP SETS AND CONTAINER. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Abbott Laboratories (Columbus, US). The FDA issued a Cleared decision on August 25, 1992 after a review of 139 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 Abbott Laboratories devices

Submission Details

510(k) Number K921697 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1992
Decision Date August 25, 1992
Days to Decision 139 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 130d · This submission: 139d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 141
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K921697.
FLEXIFLO LAPAROSCOPIC GASTROSTOMY KIT
K924697 · Abbott Laboratories · Aug 1993
BARD GAUDERER UNIVERSAL PERCUTANEOUS ENDOSCOPIC
K915841 · C.R. Bard, Inc. · Jun 1993
NON-BALLOON REPLACEMENT GASTROSTOMY SYSTEM
K915837 · C.R. Bard, Inc. · Mar 1993
FLEXIFLO QUANTUM ENT. PUMP SETS AND ENT. NUT. CONT
K915735 · Abbott Laboratories · Jun 1992
FLEXIFLO OVER-THE-GUIDEWIRE GASTROSTOMY KIT
K915110 · Abbott Laboratories · Apr 1992
SAECG CARDIOGRAPH MODEL M1754A
K913997 · Hewlett-Packard Co. · Mar 1992