Cleared Traditional

K832252 - CLIRANS TAF06 HOLLOW FIBER DIALYZER

K832252 is an FDA 510(k) clearance for CLIRANS TAF06 HOLLOW FIBER DIALYZER, manufactured by Terumo Medical Corp.. The device is a Class 2 Gastroenterology & Urology device with product code KOC cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K832252 · Terumo Medical Corp. · Gastroenterology & Urology device
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Aug 1983
Decision
46d
Days
Class 2
Risk

K832252 is an FDA 510(k) clearance for the CLIRANS TAF06 HOLLOW FIBER DIALYZER. Classified as Accessories, Blood Circuit, Hemodialysis (product code KOC), Class II - Special Controls.

Submitted by Terumo Medical Corp. (Elkton, US). The FDA issued a Cleared decision on August 26, 1983 after a review of 46 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. 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 Terumo Medical Corp. devices

FDA 510(k) Submission Details - K832252

510(k) Number K832252 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 1983
Decision Date August 26, 1983
Days to Decision 46 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
84d faster than avg
Panel avg: 130d · This submission: 46d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KOC Device Classification - Class 2, Special Controls

Product Code KOC Accessories, Blood Circuit, Hemodialysis
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 - KOC Accessories, Blood Circuit, Hemodialysis

All 124
Devices cleared under the same product code (KOC) and FDA review panel - the closest regulatory comparables to K832252.
NEPHROSS PRESTO
K832666 · Organon Teknika Corp. · Oct 1983
LUNDIA 10-2-L PARALLEL PLATE HEMODIALY
K832894 · Gambro, Inc. · Oct 1983
SINGLE PATIENT SYS. II MODEL DM-450
K832053 · Extracorporeal Medical Specialities, Inc. · Sep 1983
GF-180-L HOLLOW FIBER HEMODIALYSIS
K831606 · Gambro, Inc. · Jun 1983
CLIRANS TAF 120 HOLLOW FIBER DIALYZ. &
K831482 · Terumo Medical Corp. · Jun 1983
EXTRASENSR ULTRAFILTRATION MONITOR
K831433 · Extracorporeal Medical Specialities, Inc. · Jun 1983