Cleared Traditional

CLEARVIEW CW-10 (K870210) - FDA 510(k) Clearance

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 38
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