Cleared Traditional

K854367 - HD-SECURA HEMADIALYSIS MACHINE

K854367 is an FDA 510(k) clearance for HD-SECURA HEMADIALYSIS MACHINE, 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 48-day FDA review.

K854367 · Organon Teknika Corp. · Gastroenterology & Urology device
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Dec 1985
Decision
48d
Days
Class 2
Risk

K854367 is an FDA 510(k) clearance for the HD-SECURA HEMADIALYSIS MACHINE. 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 December 16, 1985 after a review of 48 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 - K854367

510(k) Number K854367 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 1985
Decision Date December 16, 1985
Days to Decision 48 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
82d faster than avg
Panel avg: 130d · This submission: 48d
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 K854367.
GAMBRO FLUID CONTROL MONITOR FCM 10-1
K864094 · Gambro, Inc. · Nov 1986
GAMBRO BICARBONATE MONITOR BCM 10-2
K864083 · Gambro, Inc. · Nov 1986
MONITRAL S
K861230 · Hospal Medical Corp. · Apr 1986
COBE SYSTEM 3
K851306 · Cobe Laboratories, Inc. · Jun 1985
BSM 2000 DIALYSIS MACHINE - MODIFIED
K850569 · Organon Teknika Corp. · Mar 1985
MBM(TM) MONITRAL (R) BICARBONATE MODULE
K850179 · Hospal Medical Corp. · Feb 1985