Cleared Traditional

K952625 - COAGUCHEK SYSTEM

K952625 is an FDA 510(k) clearance for COAGUCHEK SYSTEM, manufactured by Boehringer Mannheim Corp.. The device is a Class 2 Hematology device with product code JPA cleared through the Traditional 510(k) pathway after a 166-day FDA review.

K952625 · Boehringer Mannheim Corp. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1995
Decision
166d
Days
Class 2
Risk

K952625 is an FDA 510(k) clearance for the COAGUCHEK SYSTEM. Classified as System, Multipurpose For In Vitro Coagulation Studies (product code JPA), Class II - Special Controls.

Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on November 21, 1995 after a review of 166 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5425 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Boehringer Mannheim Corp. devices

FDA 510(k) Submission Details - K952625

510(k) Number K952625 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1995
Decision Date November 21, 1995
Days to Decision 166 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d slower than avg
Panel avg: 113d · This submission: 166d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JPA Device Classification - Class 2, Special Controls

Product Code JPA System, Multipurpose For In Vitro Coagulation Studies
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5425
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 - JPA System, Multipurpose For In Vitro Coagulation Studies

All 119
Devices cleared under the same product code (JPA) and FDA review panel - the closest regulatory comparables to K952625.
AMAX CS-190 COAGULATION ANALYZER SYSTEM
K955720 · Sigma Diagnostics, Inc. · Mar 1996
KC 1A COAGULATION ANALYZER/SET
K955724 · Sigma Diagnostics, Inc. · Mar 1996
KC 4A MICRO COAGULATION ANALYZER SET/SYSTEM
K955735 · Sigma Diagnostics, Inc. · Mar 1996
ACL FUTURA COAGULATION SYSTEM
K951891 · Instrumentation Laboratory CO · Nov 1995
CASCASE 480 SNSLYZER
K951497 · Helena Laboratories · Sep 1995
BEHRING FIBRINTIMER A
K926551 · Behring Diagnostics, Inc. · Apr 1995