Cleared Traditional

K915213 - CORVAC BLOOD COLLECTION TUBE

K915213 is the FDA 510(k) clearance for CORVAC BLOOD COLLECTION TUBE by Sherwood Medical Co.. It is a Class 2 Chemistry device (product code GIM) cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K915213 · Sherwood Medical Co. · Chemistry device
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Jan 1992
Decision
51d
Days
Class 2
Risk

K915213 is an FDA 510(k) clearance for the CORVAC BLOOD COLLECTION TUBE. Classified as Tubes, Vacuum Sample, With Anticoagulant (product code GIM), Class II - Special Controls.

Submitted by Sherwood Medical Co. (St. Louis, US). The FDA issued a Cleared decision on January 8, 1992 after a review of 51 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1675 - the FDA in vitro diagnostics and chemistry 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

Submission Details

510(k) Number K915213 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1991
Decision Date January 08, 1992
Days to Decision 51 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 88d · This submission: 51d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GIM Tubes, Vacuum Sample, With Anticoagulant
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1675
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 Chemistry devices follow this clearance model.

Regulatory Peers - GIM Tubes, Vacuum Sample, With Anticoagulant

All 20
Devices cleared under the same product code (GIM) and FDA review panel - the closest regulatory comparables to K915213.
DIRECTDRAW SUPERSERUM
K921778 · International Technidyne Corp. · May 1992
VACUTAINER(R) BRAND SAFETY-LOK BLOOD COLLECT SET
K921636 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1992
VACUTAINER KIT
K914901 · Abbott Laboratories · Jan 1992
QS90 SMOOTH E ARTERIAL BLOOD SAMPLER
K896514 · Radiometer America, Inc. · Jan 1990
ACCUFIBRIN(TM) BLOOD COLLECTION SYSTEM AF100
K882501 · Terumo Medical Corp. · Jul 1988
LIQUAEMIB SODIUM PRESERVATIVE, ETC.
K771304 · Organon, Inc. · Aug 1977