Cleared Traditional

K875061 - MONOJECT SAMPLETTE AMBER CAPILLARY SERUM SEPARATOR

K875061 is an FDA 510(k) clearance for MONOJECT SAMPLETTE AMBER CAPILLARY SERU..., manufactured by Sherwood Medical Co.. The device is a Class 1 Hematology device with product code GIO cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K875061 · Sherwood Medical Co. · Hematology device
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Jan 1988
Decision
34d
Days
Class 1
Risk

K875061 is an FDA 510(k) clearance for the MONOJECT SAMPLETTE AMBER CAPILLARY SERUM SEPARATOR. Classified as Tube, Collection, Capillary Blood (product code GIO), Class I - General Controls.

Submitted by Sherwood Medical Co. (St. Louis, US). The FDA issued a Cleared decision on January 12, 1988 after a review of 34 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 Co. devices

FDA 510(k) Submission Details - K875061

510(k) Number K875061 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1987
Decision Date January 12, 1988
Days to Decision 34 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
79d faster than avg
Panel avg: 113d · This submission: 34d
Pathway characteristics
Predicate-based equivalence.

GIO Device Classification - Class 1, General Controls

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.

Regulatory Peers - GIO Tube, Collection, Capillary Blood

All 12
Devices cleared under the same product code (GIO) and FDA review panel - the closest regulatory comparables to K875061.
QUICK-DRAW CAPILLARY WHOLE BLOOD COLLECTION SYSTEM
K972969 · Innovative Medical Technologies, Inc. · Sep 1997
MONOJECT SAMPLETTE SEPARATOR TUBE
K941291 · Sherwood Medical Co. · Oct 1994
VENTRESCREEN CAPILLARY BLOOD COLLECTION TUBE
K873647 · Ventrex Laboratories, Inc. · Oct 1987
CORNING BLOOD COLLECTION CAPILLARY TUBES
K850806 · Corning Medical & Scientific · Mar 1985
MICRO HEMATOCRIT CAPILLARY TUBES
K843892 · Abco Dealers, Inc. · Nov 1984
MONOJET SAMPLETTE ADAPTERS
K832578 · Sherwood Medical Co. · Aug 1983