Cleared Traditional

K882539 - CLEANTECH SYSTEM

K882539 is an FDA 510(k) clearance for CLEANTECH SYSTEM, manufactured by Schiff & Co.. The device is a Class 2 Chemistry device with product code JKA cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K882539 · Schiff & Co. · Chemistry device
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Aug 1988
Decision
48d
Days
Class 2
Risk

K882539 is an FDA 510(k) clearance for the CLEANTECH SYSTEM. Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by Schiff & Co. (West Cadwell, US). The FDA issued a Cleared decision on August 8, 1988 after a review of 48 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 Schiff & Co. devices

FDA 510(k) Submission Details - K882539

510(k) Number K882539 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 1988
Decision Date August 08, 1988
Days to Decision 48 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 88d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JKA Device Classification - Class 2, Special Controls

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 144
Devices cleared under the same product code (JKA) and FDA review panel - the closest regulatory comparables to K882539.
CIBA CORNING BLOOD COLLECTION CAPILLARY TUBE
K883813 · Ciba Corning Diagnostics Corp. · Nov 1988
MONOJECT(R) TRACE ELEMENT BLOOD COLLECTION TUBE
K883320 · Sherwood Medical Co. · Sep 1988
MONOJECT(R) SNAP-OVER SAFETY CAP
K882614 · Sherwood Medical Co. · Aug 1988
HR VACUTRAC
K881201 · Icu Medical, Inc. · May 1988
RESUBMISSION OF THE KLEERZIT REAGENT
K864866 · Advanced Biomedical Methods, Inc. · Mar 1987
DYNALUME(TM) REMOVAWELL STRIPS (NO. 011-010-7403)
K864863 · Dynatech Laboratories, Inc. · Jan 1987