Cleared Traditional

K950247 - TS 564/PF

K950247 is an FDA 510(k) clearance for TS 564/PF, manufactured by Bressler, Amery & Ross. The device is a Class 2 Gastroenterology & Urology device with product code FJK cleared through the Traditional 510(k) pathway after a 301-day FDA review.

K950247 · Bressler, Amery & Ross · Gastroenterology & Urology device
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Nov 1995
Decision
301d
Days
Class 2
Risk

K950247 is an FDA 510(k) clearance for the TS 564/PF. Classified as Set, Tubing, Blood, With And Without Anti-regurgitation Valve (product code FJK), Class II - Special Controls.

Submitted by Bressler, Amery & Ross (Morristown, US). The FDA issued a Cleared decision on November 17, 1995 after a review of 301 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5820 - 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. Elevated predicate reliance profile. 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 Bressler, Amery & Ross devices

FDA 510(k) Submission Details - K950247

510(k) Number K950247 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 1995
Decision Date November 17, 1995
Days to Decision 301 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
171d slower than avg
Panel avg: 130d · This submission: 301d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FJK Device Classification - Class 2, Special Controls

Product Code FJK Set, Tubing, Blood, With And Without Anti-regurgitation Valve
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5820
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 - FJK Set, Tubing, Blood, With And Without Anti-regurgitation Valve

All 45
Devices cleared under the same product code (FJK) and FDA review panel - the closest regulatory comparables to K950247.
BLOOD TUBING ACCESSORY WITH CLAVE CONNECTOR
K983559 · Icu Medical, Inc. · Dec 1998
COMBILINES HEMODIALYSIS BLOOD TUBING SET
K962081 · National Medical Care, Medical Products Div., Inc. · Nov 1996
BRAUN HEMODIALYSIS BLOOD CIRCUITS
K952631 · B.Braun Medical, Inc. · Apr 1996
ARTERIAL & VENOUS BLOOD TUBING SETS FOR HEMODIALYSIS
K934803 · Baxter Healthcare Corp · Dec 1993
HEMODIALYSIS BLOOD TUBING SET
K920797 · National Medical Care, Medical Products Div., Inc. · Sep 1992
SERAFLO ARTERIAL AND VENOUS BLOODLINE SETS
K913526 · Althin Medical AB an Affiliate of Baxter Intl · Nov 1991