Cleared Traditional

K870210 - CLEARVIEW CW-10

K870210 is an FDA 510(k) clearance for CLEARVIEW CW-10, manufactured by Clearview Instruments, Inc.. The device is a Class 2 Hematology device with product code GKR cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K870210 · Clearview Instruments, Inc. · Hematology device
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Apr 1987
Decision
98d
Days
Class 2
Risk

K870210 is an FDA 510(k) clearance for the CLEARVIEW CW-10. Classified as System, Hemoglobin, Automated (product code GKR), Class II - Special Controls.

Submitted by Clearview Instruments, Inc. (Stow, US). The FDA issued a Cleared decision on April 28, 1987 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5620 - 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 Clearview Instruments, Inc. devices

FDA 510(k) Submission Details - K870210

510(k) Number K870210 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 1987
Decision Date April 28, 1987
Days to Decision 98 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 113d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GKR Device Classification - Class 2, Special Controls

Product Code GKR System, Hemoglobin, Automated
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5620
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 - GKR System, Hemoglobin, Automated

All 30
Devices cleared under the same product code (GKR) and FDA review panel - the closest regulatory comparables to K870210.
AVL OMNI ANALYZER
K954018 · Avl Scientific Corp. · Oct 1995
HEMOGLOBIN REAGENT
K910745 · Toa Medical Electronics USA, Inc. · Jul 1991
CIBA CORNING MODEL 280 PH/BLOOD GAS SYSTEM
K880353 · Ciba Corning Diagnostics Corp. · Jun 1988
HEMOGLOBIN REAGENT SET
K841057 · Medical Specialties, Inc. · Mar 1984
KING DIAGNOSTICS HEMOGLOBIN TEST
K812127 · King Diagnostics, Inc. · Aug 1981
HEMESPEC II
K803015 · Helena Laboratories · Dec 1980