Cleared Traditional

K822508 - MINISAMPLER TM

K822508 is the FDA 510(k) clearance for MINISAMPLER TM by Bms, Inc.. It is a Class 2 Hematology device (product code JKA) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K822508 · Bms, Inc. · Hematology device
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Oct 1982
Decision
63d
Days
Class 2
Risk

K822508 is an FDA 510(k) clearance for the MINISAMPLER TM. Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by Bms, Inc. (Walker, US). The FDA issued a Cleared decision on October 22, 1982 after a review of 63 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 Bms, Inc. devices

Submission Details

510(k) Number K822508 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1982
Decision Date October 22, 1982
Days to Decision 63 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 113d · This submission: 63d
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 118
Devices cleared under the same product code (JKA) and FDA review panel - the closest regulatory comparables to K822508.
LITHIUM HEPARINIZED BLOOD COLLECT-TUBE
K831242 · American Dade · May 1983
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
MONOJECT STERILE CORVAC BLOOD TUBE
K812285 · Sherwood Medical Co. · Aug 1981
ISOLATOR SYSTEM
K810664 · E.I. Dupont DE Nemours & Co., Inc. · Mar 1981