Cleared Traditional

K770981 - LANCER CAPILLARY BLOOD SERUM SEPARATOR (FDA 510(k) Clearance)

Class I Hematology device.

K770981 · Sherwood Medical Industries · Hematology device
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Jul 1977
Decision
41d
Days
Class 1
Risk

K770981 is an FDA 510(k) clearance for the LANCER CAPILLARY BLOOD SERUM SEPARATOR. Classified as Tube, Collection, Capillary Blood (product code GIO), Class I - General Controls.

Submitted by Sherwood Medical Industries (Mchenry, US). The FDA issued a Cleared decision on July 11, 1977 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.6150 - 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 Sherwood Medical Industries devices

Submission Details

510(k) Number K770981 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1977
Decision Date July 11, 1977
Days to Decision 41 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 113d · This submission: 41d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GIO Tube, Collection, Capillary Blood
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.6150
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.