Cleared Abbreviated

K081313 - SH14 HEMOCONCENTRATOR

K081313 is an FDA 510(k) clearance for SH14 HEMOCONCENTRATOR, manufactured by Sorin Group Italia S.R.L.. The device is a Class 2 Gastroenterology & Urology device with product code KDI cleared through the Abbreviated 510(k) pathway after a 194-day FDA review.

K081313 · Sorin Group Italia S.R.L. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2008
Decision
194d
Days
Class 2
Risk

K081313 is an FDA 510(k) clearance for the SH14 HEMOCONCENTRATOR. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Sorin Group Italia S.R.L. (Waltham, US). The FDA issued a Cleared decision on November 19, 2008 after a review of 194 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5860 - the FDA gastroenterology and urology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K081313

510(k) Number K081313 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2008
Decision Date November 19, 2008
Days to Decision 194 days
Submission Type Abbreviated
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
63d slower than avg
Panel avg: 131d · This submission: 194d
Pathway characteristics
Standards-based clearance path.

KDI Device Classification - Class 2, Special Controls

Product Code KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5860
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 - KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

All 344
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K081313.
XENIUM XPH, MODELS 110, 130, 150, 170, 190 AND 210
K083778 · Baxter Healthcare Corporation · Feb 2009
FRESENIUS MODEL 2008T HEMODIALYSIS MACHINE
K080964 · Fresenius Medical Care North America · Jan 2009
OMNI-DL SYSTEM
K080650 · Transvivo, Inc. · Nov 2008
OPTIFLUX F250NR, MODEL 0500325E
K082414 · Fresenius Medical Care North America · Oct 2008
ASAHI REXEED-SX/LX DIALYZERS, MODELS: 13SX, 15SX, 18SX, 21SX, 25SX, 13LX, 15LX, 18LX, 21LX
K082515 · Asahi Kasei Medical Co., Ltd. · Oct 2008
PRISMAFLEX M150 SET
K080519 · Gambro Renal Products, Inc. · Jun 2008
K081313 · SH14 HEMOCONCENTRATOR
Download PDF FDA Summary Sorin Group Italia S.…