Cleared Traditional

K851669 - MONITOR IV PLUS

K851669 is an FDA 510(k) clearance for MONITOR IV PLUS, manufactured by Helena Laboratories. The device is a Class 2 Hematology device with product code JOZ cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K851669 · Helena Laboratories · Hematology device
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Jul 1985
Decision
91d
Days
Class 2
Risk

K851669 is an FDA 510(k) clearance for the MONITOR IV PLUS. Classified as System, Automated Platelet Aggregation (product code JOZ), Class II - Special Controls.

Submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on July 23, 1985 after a review of 91 days - within the typical 510(k) review window.

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: 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 Helena Laboratories devices

FDA 510(k) Submission Details - K851669

510(k) Number K851669 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1985
Decision Date July 23, 1985
Days to Decision 91 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
22d faster than avg
Panel avg: 113d · This submission: 91d
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 30
Devices cleared under the same product code (JOZ) and FDA review panel - the closest regulatory comparables to K851669.
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
HELENA RISTOCETIN
K800432 · Helena Laboratories · Mar 1980
PLATELET AGGREGATION REAGENTS
K800146 · Pacific Hemostasis · Feb 1980
ELVI 840 AGGREGOMETER
K791577 · Volu Sol Medical Industries · Sep 1979