Cleared Traditional

RETRO REPAIR KIT, MODEL PRRK5 (K022644) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K022644 · Spire Biomedical, Inc. · Gastroenterology & Urology device
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Nov 2002
Decision
90d
Days
Class 2
Risk

K022644 is an FDA 510(k) clearance for the RETRO REPAIR KIT, MODEL PRRK5. Classified as Kit, Repair, Catheter, Hemodialysis (product code NFK), Class II - Special Controls.

Submitted by Spire Biomedical, Inc. (Bedford, US). The FDA issued a Cleared decision on November 6, 2002 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5540 - 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 Spire Biomedical, Inc. devices

Submission Details

510(k) Number K022644 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received August 08, 2002
Decision Date November 06, 2002
Days to Decision 90 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 130d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NFK Kit, Repair, Catheter, Hemodialysis
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5540
Definition Hemodialysis Tray
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 - NFK Kit, Repair, Catheter, Hemodialysis

All 10
Devices cleared under the same product code (NFK) and FDA review panel - the closest regulatory comparables to K022644.
CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
K101261 · C.R. Bard, Inc. · Jul 2010
CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
K063446 · C.R. Bard, Inc. · Dec 2006
CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
K030442 · C.R. Bard, Inc. · Jul 2003
CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
K022561 · C.R. Bard, Inc. · Aug 2002
CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
K011015 · C.R. Bard, Inc. · Jun 2001