Cleared Traditional

K862302 - BLOOD PLATELET ASSAY METHOD & APPARATUS

K862302 is an FDA 510(k) clearance for BLOOD PLATELET ASSAY METHOD & APPARATUS, manufactured by Bellhouse Medical, Inc.. The device is a Class 2 Hematology device with product code JOZ cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K862302 · Bellhouse Medical, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1986
Decision
44d
Days
Class 2
Risk

K862302 is an FDA 510(k) clearance for the BLOOD PLATELET ASSAY METHOD & APPARATUS. Classified as System, Automated Platelet Aggregation (product code JOZ), Class II - Special Controls.

Submitted by Bellhouse Medical, Inc. (Washington, US). The FDA issued a Cleared decision on July 31, 1986 after a review of 44 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5700 - 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 Bellhouse Medical, Inc. devices

FDA 510(k) Submission Details - K862302

510(k) Number K862302 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1986
Decision Date July 31, 1986
Days to Decision 44 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 113d · This submission: 44d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOZ Device Classification - Class 2, Special Controls

Product Code JOZ System, Automated Platelet Aggregation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5700
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 - JOZ System, Automated Platelet Aggregation

All 31
Devices cleared under the same product code (JOZ) and FDA review panel - the closest regulatory comparables to K862302.
CHRONO-LOG WHOLE BLOOD AGGREGOMETER (WBA) 591/592
K962426 · Chrono-Log Corp. · Oct 1996
CENTOCOR AGGRESTAT, COLLAGEN REAGENT, CONTROL REAGENT
K954997 · Centocor, Inc. · Jan 1996
AGGRO/LINK VW COFACTOR SOFTWARE
K940792 · Chrono-Log Corp. · Oct 1994
MONITOR IV PLUS
K851669 · Helena Laboratories · Jul 1985
HELENA RISTOCETIN
K800432 · Helena Laboratories · Mar 1980
PLATELET AGGREGATION REAGENTS
K800146 · Pacific Hemostasis · Feb 1980