Cleared Traditional

K832666 - NEPHROSS PRESTO

K832666 is an FDA 510(k) clearance for NEPHROSS PRESTO, manufactured by Organon Teknika Corp.. The device is a Class 2 Gastroenterology & Urology device with product code KOC cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K832666 · Organon Teknika Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1983
Decision
66d
Days
Class 2
Risk

K832666 is an FDA 510(k) clearance for the NEPHROSS PRESTO. Classified as Accessories, Blood Circuit, Hemodialysis (product code KOC), Class II - Special Controls.

Submitted by Organon Teknika Corp. (Mchenry, US). The FDA issued a Cleared decision on October 14, 1983 after a review of 66 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 Organon Teknika Corp. devices

FDA 510(k) Submission Details - K832666

510(k) Number K832666 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 1983
Decision Date October 14, 1983
Days to Decision 66 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
64d faster than avg
Panel avg: 130d · This submission: 66d
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 K832666.
ERIKA DI-ALA-KIT-SINGLE DIALYSIS ON/OF
K833252 · Erika, Inc. · Dec 1983
BLOOD SAFETY MODULE BSM2
K833440 · Hospal Medical Corp. · Dec 1983
CLIRANS MODEL TAF 15 HOLLOW FIBER
K833503 · Terumo Medical Corp. · Dec 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
CLIRANS TAF06 HOLLOW FIBER DIALYZER
K832252 · Terumo Medical Corp. · Aug 1983