Cleared Traditional

K870623 - ENTERAL ADMINISTRATION SET

K870623 is an FDA 510(k) clearance for ENTERAL ADMINISTRATION SET, manufactured by Plasco, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FPD cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K870623 · Plasco, Inc. · Gastroenterology & Urology device
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Jun 1987
Decision
134d
Days
Class 2
Risk

K870623 is an FDA 510(k) clearance for the ENTERAL ADMINISTRATION SET. Classified as Tube, Feeding (product code FPD), Class II - Special Controls.

Submitted by Plasco, Inc. (Gurnee, US). The FDA issued a Cleared decision on June 26, 1987 after a review of 134 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 Plasco, Inc. devices

FDA 510(k) Submission Details - K870623

510(k) Number K870623 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1987
Decision Date June 26, 1987
Days to Decision 134 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
3d slower than avg
Panel avg: 131d · This submission: 134d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPD Device Classification - Class 2, Special Controls

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.

Regulatory Peers - FPD Tube, Feeding

All 29
Devices cleared under the same product code (FPD) and FDA review panel - the closest regulatory comparables to K870623.
WILTEK GASTRIC FEEDING TUBE
K894860 · Wiltek Medical, Inc. · Dec 1989
KENDALL CURITY FEEDING TUBES
K892431 · The Kendal Co. · May 1989
ENTERAL FEEDING TUBE
K890116 · Hdc Corp. · Apr 1989
ADMINISTRATION SET
K810131 · G.D. Searle and Co. · Feb 1981
DOBBHOFF ENTERIC FEEDING BAG
K781385 · Biosearch Medical Products, Inc. · Sep 1978
TUBE, FEEDING, ARGYLE
K760137 · Sherwood Medical Industries · Jul 1976