Cleared Traditional

K832053 - SINGLE PATIENT SYS. II MODEL DM-450

K832053 is the FDA 510(k) clearance for SINGLE PATIENT SYS. II MODEL DM-450 by Extracorporeal Medical Specialities, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KOC) cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K832053 · Extracorporeal Medical Specialities, Inc. · Gastroenterology & Urology device
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Sep 1983
Decision
94d
Days
Class 2
Risk

K832053 is an FDA 510(k) clearance for the SINGLE PATIENT SYS. II MODEL DM-450. Classified as Accessories, Blood Circuit, Hemodialysis (product code KOC), Class II - Special Controls.

Submitted by Extracorporeal Medical Specialities, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 29, 1983 after a review of 94 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Extracorporeal Medical Specialities, Inc. devices

Submission Details

510(k) Number K832053 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 1983
Decision Date September 29, 1983
Days to Decision 94 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
36d faster than avg
Panel avg: 130d · This submission: 94d
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 80
Devices cleared under the same product code (KOC) and FDA review panel - the closest regulatory comparables to K832053.
CLIRANS MODEL TAF 15 HOLLOW FIBER
K833503 · Terumo Medical Corp. · Dec 1983
NEPHROSS PRESTO
K832666 · Organon Teknika Corp. · Oct 1983
LUNDIA 10-2-L PARALLEL PLATE HEMODIALY
K832894 · Gambro, Inc. · Oct 1983
CLIRANS TAF06 HOLLOW FIBER DIALYZER
K832252 · Terumo Medical Corp. · Aug 1983
GF-180-L HOLLOW FIBER HEMODIALYSIS
K831606 · Gambro, Inc. · Jun 1983
CLIRANS TAF 120 HOLLOW FIBER DIALYZ. &
K831482 · Terumo Medical Corp. · Jun 1983