Cleared Traditional

K823176 - MONOJECT SAMPLETTE CAPILLARY SERUM SEP

K823176 is the FDA 510(k) clearance for MONOJECT SAMPLETTE CAPILLARY SERUM SEP by Sherwood Medical Co.. It is a Class 2 Hematology device (product code JKA) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K823176 · Sherwood Medical Co. · Hematology device
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Nov 1982
Decision
27d
Days
Class 2
Risk

K823176 is an FDA 510(k) clearance for the MONOJECT SAMPLETTE CAPILLARY SERUM SEP. Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by Sherwood Medical Co. (Mchenry, US). The FDA issued a Cleared decision on November 22, 1982 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 862.1675 - 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

Submission Details

510(k) Number K823176 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1982
Decision Date November 22, 1982
Days to Decision 27 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
86d faster than avg
Panel avg: 113d · This submission: 27d
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 Hematology 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 K823176.
LIPOSOL
K830472 · Quest Medical, Inc. · Jun 1983
LITHIUM HEPARINIZED BLOOD COLLECT-TUBE
K831242 · American Dade · May 1983
MONOJECT SAMPLETTE CAPILLARY BLOOD COLL
K823836 · Sherwood Medical Co. · Jan 1983
MONOJECT CORVAC STAT VAC TUBE W/THROM
K820717 · Sherwood Medical Co. · Apr 1982
MONOJECT STERILE CORVAC BLOOD TUBE
K812285 · Sherwood Medical Co. · Aug 1981
ISOLATOR SYSTEM
K810664 · E.I. Dupont DE Nemours & Co., Inc. · Mar 1981