Cleared Special

K012242 - FRESENIUS ARTERIAL BLOODLINE SETS FOR HEMODIALYSIS, FRESENIUS COMBI SETS HEMODIALYSIS BLOOD TUBING SETS

K012242 is an FDA 510(k) clearance for FRESENIUS ARTERIAL BLOODLINE SETS FOR H..., manufactured by Fresenius Medical Care North America. The device is a Class 2 Gastroenterology & Urology device with product code FJK cleared through the Special 510(k) pathway after a 30-day FDA review.

K012242 · Fresenius Medical Care North America · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2001
Decision
30d
Days
Class 2
Risk

K012242 is an FDA 510(k) clearance for the FRESENIUS ARTERIAL BLOODLINE SETS FOR HEMODIALYSIS, FRESENIUS COMBI SETS HEMO.... Classified as Set, Tubing, Blood, With And Without Anti-regurgitation Valve (product code FJK), Class II - Special Controls.

Submitted by Fresenius Medical Care North America (Lexington, US). The FDA issued a Cleared decision on August 16, 2001 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5820 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K012242

510(k) Number K012242 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 2001
Decision Date August 16, 2001
Days to Decision 30 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 131d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 76
Devices cleared under the same product code (FJK) and FDA review panel - the closest regulatory comparables to K012242.
JMS BLOOD TUBING SETS
K032975 · Jms North America Corp. · Aug 2004
RENAX HEMODIALYSIS BLOOD TUBING SET
K014140 · Sunder Biomedical Tech. Co., Ltd. · Nov 2002
BIOTEQUE 3 IN 1 HEMODIALYSIS BLOOD TUBING PACK
K013634 · Bioteque Corp. · Jul 2002
HEMOSAFE PATIENT CONNECTOR FOR FRESENIUS BLOODLINES, MODEL 04-9100-0
K001873 · Fresenius Medical Care North America · Jul 2000
FRESENIUS COMBILINES LOW VOLUME BLOOD TUBING SET, MODELS 03-2291 (POST PUMP) AND 03-2292 (PRE-PUMP)
K001107 · Fresenius Medical Care North America · Jun 2000
FRESENIUS COMBILLINES SINGLE NEEDLE BLOOD TUBING SET, CATALOG #03-2290
K000451 · Fresenius Medical Care North America · May 2000
K012242 · FRESENIUS ARTERIAL BLOODLINE SETS FOR HEMODIALYSIS, FRESENIUS COMBI SETS HEMODIALYSIS BLOOD TUBING SETS
Download PDF FDA Summary Fresenius Medical Car…