Cleared Traditional

K894870 - WILTEK NASAL BILIARY DRAINAGE SET

K894870 is an FDA 510(k) clearance for WILTEK NASAL BILIARY DRAINAGE SET, manufactured by Wiltek Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code BSS cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K894870 · Wiltek Medical, Inc. · Gastroenterology & Urology device
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Dec 1989
Decision
143d
Days
Class 2
Risk

K894870 is an FDA 510(k) clearance for the WILTEK NASAL BILIARY DRAINAGE SET. Classified as Tube, Nasogastric (product code BSS), Class II - Special Controls.

Submitted by Wiltek Medical, Inc. (Winston-Salem, US). The FDA issued a Cleared decision on December 21, 1989 after a review of 143 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 Wiltek Medical, Inc. devices

FDA 510(k) Submission Details - K894870

510(k) Number K894870 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1989
Decision Date December 21, 1989
Days to Decision 143 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
13d slower than avg
Panel avg: 130d · This submission: 143d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BSS Device Classification - Class 2, Special Controls

Product Code BSS Tube, Nasogastric
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 - BSS Tube, Nasogastric

Devices cleared under the same product code (BSS) and FDA review panel - the closest regulatory comparables to K894870.
ENTERAL FEEDING TUBE
K051480 · Biosearch Medical Products, Inc. · Oct 2005
ASPISAFE GASTRIC TUBE
K961711 · B.Braun Medical, Inc. · Jun 1997
ARGYLE POLYURETHANE SALEM SUMP TUBE
K910479 · Sherwood Medical Co. · Apr 1991
TECNOL NASO-GASTRIC TUBE HOLDER
K891187 · Tecnol New Jersey Wound Care, Inc. · May 1989
FLEXIFLO ENTERAL PUMP SET
K791531 · Abbott Laboratories · Sep 1979