Cleared Traditional

K896206 - STATSPIN STATSAMPLER

K896206 is an FDA 510(k) clearance for STATSPIN STATSAMPLER, manufactured by Statspin Technologies. The device is a Class 2 Chemistry device with product code JKA cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K896206 · Statspin Technologies · Chemistry device
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Nov 1989
Decision
27d
Days
Class 2
Risk

K896206 is an FDA 510(k) clearance for the STATSPIN STATSAMPLER. Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by Statspin Technologies (Norwood, US). The FDA issued a Cleared decision on November 22, 1989 after a review of 27 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.

FDA 510(k) Submission Details - K896206

510(k) Number K896206 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1989
Decision Date November 22, 1989
Days to Decision 27 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
62d faster than avg
Panel avg: 89d · This submission: 27d
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 240
Devices cleared under the same product code (JKA) and FDA review panel - the closest regulatory comparables to K896206.
SECUTAINER
K902709 · Preserve · Jul 1990
MICROTEK MEDICAL'S BLOOD COLLECTION KIT
K900726 · Microbio-Medics, Inc. · May 1990
VENOJECT II BLOOD COLLECTION TUBES
K900309 · Terumo Medical Corp. · Mar 1990
PRO-JECT(TM) SAFETY NEEDLE HOLDER
K892665 · Pro-Tec Containers, Inc. · Oct 1989
PINSET
K884970 · Safety Diagnostics, Inc. · Sep 1989
STATSPIN MINI-PLASMA
K893613 · Statspin Technologies · Aug 1989
K896206 · STATSPIN STATSAMPLER
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