Cleared Traditional

K831409 - HAEMOLYTE SOLUTION

K831409 is the FDA 510(k) clearance for HAEMOLYTE SOLUTION by Dialysis Clinic, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KOC) cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K831409 · Dialysis Clinic, Inc. · Gastroenterology & Urology device
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Jun 1983
Decision
59d
Days
Class 2
Risk

K831409 is an FDA 510(k) clearance for the HAEMOLYTE SOLUTION. Classified as Accessories, Blood Circuit, Hemodialysis (product code KOC), Class II - Special Controls.

Submitted by Dialysis Clinic, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 30, 1983 after a review of 59 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 Dialysis Clinic, Inc. devices

Submission Details

510(k) Number K831409 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 1983
Decision Date June 30, 1983
Days to Decision 59 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 130d · This submission: 59d
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 122
Devices cleared under the same product code (KOC) and FDA review panel - the closest regulatory comparables to K831409.
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
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
EXTRASENSR ULTRAFILTRATION MONITOR
K831433 · Extracorporeal Medical Specialities, Inc. · Jun 1983