Cleared Traditional

K921597 - CAVH/CVVH/CAVHD SET MODEL #HT-HF/505

K921597 is an FDA 510(k) clearance for CAVH/CVVH/CAVHD SET MODEL #HT-HF/505, manufactured by Haemotronic, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FJK cleared through the Traditional 510(k) pathway after a 1057-day FDA review.

K921597 · Haemotronic, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1995
Decision
1057d
Days
Class 2
Risk

K921597 is an FDA 510(k) clearance for the CAVH/CVVH/CAVHD SET MODEL #HT-HF/505. Classified as Set, Tubing, Blood, With And Without Anti-regurgitation Valve (product code FJK), Class II - Special Controls.

Submitted by Haemotronic, Inc. (Fairfield, US). The FDA issued a Cleared decision on February 24, 1995 after a review of 1057 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: 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 Haemotronic, Inc. devices

FDA 510(k) Submission Details - K921597

510(k) Number K921597 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1992
Decision Date February 24, 1995
Days to Decision 1057 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
927d slower than avg
Panel avg: 130d · This submission: 1057d
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 K921597.
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