Cleared Traditional

K840062 - BSM 2000 DIALYSIS MACHINE

K840062 is an FDA 510(k) clearance for BSM 2000 DIALYSIS MACHINE, 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 73-day FDA review.

K840062 · Organon Teknika Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1984
Decision
73d
Days
Class 2
Risk

K840062 is an FDA 510(k) clearance for the BSM 2000 DIALYSIS MACHINE. 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 March 22, 1984 after a review of 73 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 - K840062

510(k) Number K840062 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 1984
Decision Date March 22, 1984
Days to Decision 73 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
57d faster than avg
Panel avg: 130d · This submission: 73d
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 K840062.
FILTRYZER HOLLOW FIBER ARTIF. KIDNEY
K831176 · Erika, Inc. · Jun 1984
MAKS CENTRAL DELIVERY SYS-11-200 ETC
K840859 · Erika, Inc. · May 1984
DIALYSIS ADMIN. SET - I.V.
K840654 · Cp Medical · May 1984
BLOOD TUBING
K834596 · Renal Systems, Inc. · Feb 1984
EXP* 500 PARALLEL PLATE DIALYZER
K840057 · Extracorporeal Medical Specialities, Inc. · Feb 1984
EXP* 700 PARALLEL PLATE DIALYZER
K840146 · Extracorporeal Medical Specialities, Inc. · Feb 1984