Cleared Traditional

CLIRANS TAF06 HOLLOW FIBER DIALYZER (K832252) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 36

Devices cleared under the same product code (KOC) and FDA review panel - the closest regulatory comparables to K832252.

DUAL LUMEN NEEDLE

K833308 · Quinton, Inc. · Dec 1983

CLIRANS MODEL TAF 15 HOLLOW FIBER

K833503 · Terumo Medical Corp. · Dec 1983

NEPHROSS PRESTO

K832666 · Organon Teknika Corp. · Oct 1983

CLIRANS TAF 120 HOLLOW FIBER DIALYZ. &

K831482 · Terumo Medical Corp. · Jun 1983

C-DAK ARTIFICIAL KIDNEY

K830729 · Cordis Corp. · Mar 1983

A.V. FISTULA CANNULATION SETS

K830021 · Travenol Laboratories, S.A. · Jan 1983

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K832252

Terumo Medical Corp.

Elkton, MD · US

Regulatory profile

143 submissions 143 cleared

100% clearance rate · Active in Gastroenterology & Urology

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Sourced from FDA 510(k) public files . Updated monthly.

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