Cleared Traditional

K812285 - MONOJECT STERILE CORVAC BLOOD TUBE

K812285 is the FDA 510(k) clearance for MONOJECT STERILE CORVAC BLOOD TUBE by Sherwood Medical Co.. It is a Class 2 Chemistry device (product code JKA) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K812285 · Sherwood Medical Co. · Chemistry device
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Aug 1981
Decision
18d
Days
Class 2
Risk

K812285 is an FDA 510(k) clearance for the MONOJECT STERILE CORVAC BLOOD TUBE. Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by Sherwood Medical Co. (Walker, US). The FDA issued a Cleared decision on August 31, 1981 after a review of 18 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 K812285 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 1981
Decision Date August 31, 1981
Days to Decision 18 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 88d · This submission: 18d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
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 - JKA Tubes, Vials, Systems, Serum Separators, Blood Collection

All 115
Devices cleared under the same product code (JKA) and FDA review panel - the closest regulatory comparables to K812285.
MONOJECT SAMPLETTE CAPILLARY BLOOD COLL
K823836 · Sherwood Medical Co. · Jan 1983
MONOJECT SAMPLETTE CAPILLARY SERUM SEP
K823176 · Sherwood Medical Co. · Nov 1982
MONOJECT CORVAC STAT VAC TUBE W/THROM
K820717 · Sherwood Medical Co. · Apr 1982
ISOLATOR SYSTEM
K810664 · E.I. Dupont DE Nemours & Co., Inc. · Mar 1981
BLOOD FLUID FILTERS
K792723 · Dade, Baxter Travenol Diagnostics, Inc. · Jan 1980
AMYLOCHROME STAT SEPARATOR, TEST
K790485 · Hoffmann-La Roche, Inc. · May 1979