Cleared Traditional

K890315 - CAPILLARY FLOW DIALYZERS MODELS CT110G ...

K890315 is an FDA 510(k) clearance for CAPILLARY FLOW DIALYZERS MODELS CT110G ..., manufactured by Baxter Healthcare Corp. The device is a Class 2 Gastroenterology & Urology device with product code KDI cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K890315 · Baxter Healthcare Corp · Gastroenterology & Urology device
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Feb 1989
Decision
16d
Days
Class 2
Risk

K890315 is an FDA 510(k) clearance for the CAPILLARY FLOW DIALYZERS MODELS CT110G & CT190G. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Round Lake, US). The FDA issued a Cleared decision on February 8, 1989 after a review of 16 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 Baxter Healthcare Corp devices

FDA 510(k) Submission Details - K890315

510(k) Number K890315 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 1989
Decision Date February 08, 1989
Days to Decision 16 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
114d faster than avg
Panel avg: 130d · This submission: 16d
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 216
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K890315.
HOLLOW FIBER DIALYZER SERIES FOCUS 160/160H
K895759 · National Medical Care, Medical Products Div., Inc. · Nov 1989
FILTRAL TM 20 HEMODIALYZER/FILTER
K893742 · Hospal Medical Corp. · Jul 1989
FRESENIUS HEMOFLOW, F40M, F50M, F60M & F80M
K892262 · Fresenius USA, Inc. · Apr 1989
MULTIFLOW(TM) 60 KIT
K884365 · Hospal Medical Corp. · Dec 1988
FILTRAL TM 8 HEMODIALYZER
K884326 · Hospal Medical Corp. · Dec 1988
CARDIOFLOW 100 HEMOCONCENTRATOR/PREPARATION KIT
K883307 · Hospal Medical Corp. · Oct 1988