Cleared Traditional

K850569 - BSM 2000 DIALYSIS MACHINE - MODIFIED

K850569 is an FDA 510(k) clearance for BSM 2000 DIALYSIS MACHINE - MODIFIED, manufactured by Organon Teknika Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FKP cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K850569 · Organon Teknika Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1985
Decision
28d
Days
Class 2
Risk

K850569 is an FDA 510(k) clearance for the BSM 2000 DIALYSIS MACHINE - MODIFIED. Classified as System, Dialysate Delivery, Single Patient (product code FKP), Class II - Special Controls.

Submitted by Organon Teknika Corp. (Oklahoma City, US). The FDA issued a Cleared decision on March 12, 1985 after a review of 28 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 - K850569

510(k) Number K850569 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1985
Decision Date March 12, 1985
Days to Decision 28 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
102d faster than avg
Panel avg: 130d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FKP Device Classification - Class 2, Special Controls

Product Code FKP System, Dialysate Delivery, Single Patient
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 - FKP System, Dialysate Delivery, Single Patient

All 36
Devices cleared under the same product code (FKP) and FDA review panel - the closest regulatory comparables to K850569.
MONITRAL S
K861230 · Hospal Medical Corp. · Apr 1986
HD-SECURA HEMADIALYSIS MACHINE
K854367 · Organon Teknika Corp. · Dec 1985
COBE SYSTEM 3
K851306 · Cobe Laboratories, Inc. · Jun 1985
MBM(TM) MONITRAL (R) BICARBONATE MODULE
K850179 · Hospal Medical Corp. · Feb 1985
EXTRASENSR ULTRAFILTRATION MONITOR
K811972 · Extracorporeal Medical Specialities, Inc. · Nov 1981
B-D DRAKE WILLOCK #7000 SERIES ULTRAF
K811591 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1981