Cleared Abbreviated

K170790 - SAM CRRT Unit

K170790 is an FDA 510(k) clearance for SAM CRRT Unit, manufactured by Spectral Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KDI cleared through the Abbreviated 510(k) pathway after a 272-day FDA review.

K170790 · Spectral Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2017
Decision
272d
Days
Class 2
Risk

K170790 is an FDA 510(k) clearance for the SAM CRRT Unit, SAM Cassette CRRT. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Spectral Medical, Inc. (Toronto, CA). The FDA issued a Cleared decision on December 13, 2017 after a review of 272 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.

View all Spectral Medical, Inc. devices

FDA 510(k) Submission Details - K170790

510(k) Number K170790 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2017
Decision Date December 13, 2017
Days to Decision 272 days
Submission Type Abbreviated
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
142d slower than avg
Panel avg: 130d · This submission: 272d
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 217
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K170790.
Surdial DX Hemodialysis System
K182940 · Nipro Medical Corporation · Jul 2019
2008T BlueStar Hemodialysis Machine
K173972 · Fresenius Medical Care Renal Therapies Group, LLC · May 2018
Prismaflex System 8.10
K171671 · Baxter Healthcare Corporation · Feb 2018
NxStage System One
K171331 · Nxstage Medical, Inc. · Aug 2017
NxStage System One Plus
K170469 · Nxstage Medical, Inc. · May 2017
PrisMax Control Unit
K163530 · Baxter Healthcare Corp · May 2017