Cleared Traditional

K895142 - ENTERAL PUMP SET WITH ENTERAL SPIKE

K895142 is the FDA 510(k) clearance for ENTERAL PUMP SET WITH ENTERAL SPIKE by Delmed, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KNT) cleared through the Traditional 510(k) pathway after a 412-day FDA review.

K895142 · Delmed, Inc. · Gastroenterology & Urology device
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Oct 1990
Decision
412d
Days
Class 2
Risk

K895142 is an FDA 510(k) clearance for the ENTERAL PUMP SET WITH ENTERAL SPIKE. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Delmed, Inc. (New Brunswick, US). The FDA issued a Cleared decision on October 2, 1990 after a review of 412 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Delmed, Inc. devices

Submission Details

510(k) Number K895142 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1989
Decision Date October 02, 1990
Days to Decision 412 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
282d slower than avg
Panel avg: 130d · This submission: 412d
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 206
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K895142.
FLEXIFLO STOMATE DECOMPRESSION TUBE
K903579 · Abbott Laboratories · Nov 1990
FLEXIFLO (R) VERSA-PEG (TM) GASTROSTOMY KIT
K903325 · Abbott Laboratories · Nov 1990
WILSON-COOK VARICES TAMPONADE BALLOON CUFF
K902099 · Wilson-Cook Medical, Inc. · Nov 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