Cleared Traditional

K885035 - KOAGULAB* 32-S COAGULATION SYSTEM

K885035 is an FDA 510(k) clearance for KOAGULAB* 32-S COAGULATION SYSTEM, manufactured by Ortho Diagnostic Systems, Inc.. The device is a Class 2 Hematology device with product code GKP cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K885035 · Ortho Diagnostic Systems, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1989
Decision
60d
Days
Class 2
Risk

K885035 is an FDA 510(k) clearance for the KOAGULAB* 32-S COAGULATION SYSTEM. Classified as Instrument, Coagulation, Automated (product code GKP), Class II - Special Controls.

Submitted by Ortho Diagnostic Systems, Inc. (Raritan, US). The FDA issued a Cleared decision on February 3, 1989 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5400 - the FDA hematology 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 Ortho Diagnostic Systems, Inc. devices

FDA 510(k) Submission Details - K885035

510(k) Number K885035 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1988
Decision Date February 03, 1989
Days to Decision 60 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 113d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GKP Device Classification - Class 2, Special Controls

Product Code GKP Instrument, Coagulation, Automated
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5400
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 Hematology devices follow this clearance model.

Regulatory Peers - GKP Instrument, Coagulation, Automated

All 45
Devices cleared under the same product code (GKP) and FDA review panel - the closest regulatory comparables to K885035.
KOAGULAB 60-S COAGULATION SYSTEM
K901120 · Ortho Diagnostic Systems, Inc. · May 1990
ELECTRA 1000C AUTOMATIC COAGULATION TIMER
K894052 · Medical Laboratory Automation Systems, Inc. · Jul 1989
ELECTRA 900C AUTOMATIC COAGULATION TIMER
K884863 · Medical Laboratory Automation Systems, Inc. · Feb 1989
COAG-A-MATE(R) XM
K881281 · Organon Teknika Corp. · May 1988
COAG-A-MATE X2
K813564 · General Diagnostics · Jan 1982