Cleared Traditional

K893209 - ENTERA-FLO SPIKE SET

K893209 is the FDA 510(k) clearance for ENTERA-FLO SPIKE SET by Delmed, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KNT) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K893209 · Delmed, Inc. · Gastroenterology & Urology device
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Jul 1989
Decision
88d
Days
Class 2
Risk

K893209 is an FDA 510(k) clearance for the ENTERA-FLO SPIKE SET. 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 July 24, 1989 after a review of 88 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 Delmed, Inc. devices

Submission Details

510(k) Number K893209 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1989
Decision Date July 24, 1989
Days to Decision 88 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
42d faster than avg
Panel avg: 130d · This submission: 88d
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 K893209.
MAGNET RETRIEVAL CATHETER
K900852 · Cook, Inc. · May 1990
HOLLISTER FEEDING TUBE ATTACHMENT DEVICE
K893888 · Hollister, Inc. · Oct 1989
PEDI-TUBE(R) STYLET
K894857 · Biosearch Medical Products, Inc. · Oct 1989
PANDA(R) NEEDLE CATHETER JEJUNOSTOMY TUBE
K891109 · Concept, Inc. · May 1989
BARD GASTROSTOMY FEEDING DEVICE
K890870 · C.R. Bard, Inc. · Apr 1989
BARD MOSS(R) GASTROSTOMY TUBE
K890871 · C.R. Bard, Inc. · Apr 1989