Cleared Traditional

K854309 - GAMBRO BLOOD CONCENTRATOR SETS 16

K854309 is an FDA 510(k) clearance for GAMBRO BLOOD CONCENTRATOR SETS 16, manufactured by Gambro, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KDI cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K854309 · Gambro, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1985
Decision
49d
Days
Class 2
Risk

K854309 is an FDA 510(k) clearance for the GAMBRO BLOOD CONCENTRATOR SETS 16,60,200. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Gambro, Inc. (Lincolnshire, US). The FDA issued a Cleared decision on December 13, 1985 after a review of 49 days - a notably fast clearance 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Gambro, Inc. devices

FDA 510(k) Submission Details - K854309

510(k) Number K854309 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1985
Decision Date December 13, 1985
Days to Decision 49 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 130d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 226
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K854309.
HOSPAL BIOSPAL 1800S
K863961 · Hospal Medical Corp. · Dec 1986
HIGH EFFICIENCY HEMODIALYSIS SYSTEM
K861776 · Travenol Laboratories, S.A. · Jun 1986
GAMBRO FIBER HEMOFILTERS FH 22/66 DISPOS TUBE SETS
K860938 · Gambro, Inc. · Apr 1986
HOLLOW FIBER DIALYZER
K854586 · Travenol Laboratories, S.A. · Dec 1985
RENALFO HEMOFILTER CAVHD
K854011 · Renal Systems, Inc. · Nov 1985
FILTRAL HEMODIALYZER
K852885 · Hospal Medical Corp. · Sep 1985