Cleared Traditional

K953994 - SEDITAINER* ERYTHROCYTE SEDIMENTATION RATE (ESR) SYSTEM

K953994 is an FDA 510(k) clearance for SEDITAINER* ERYTHROCYTE SEDIMENTATION R..., manufactured by Becton Dickinson Vacutainer Systems. The device is a Class 2 Chemistry device with product code JKA cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K953994 · Becton Dickinson Vacutainer Systems · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1995
Decision
33d
Days
Class 2
Risk

K953994 is an FDA 510(k) clearance for the SEDITAINER* ERYTHROCYTE SEDIMENTATION RATE (ESR) SYSTEM. Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by Becton Dickinson Vacutainer Systems (Franklin Lake, US). The FDA issued a Cleared decision on September 26, 1995 after a review of 33 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 Becton Dickinson Vacutainer Systems devices

FDA 510(k) Submission Details - K953994

510(k) Number K953994 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 1995
Decision Date September 26, 1995
Days to Decision 33 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 88d · This submission: 33d
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 165
Devices cleared under the same product code (JKA) and FDA review panel - the closest regulatory comparables to K953994.
GREINER VACUTTE BLOOD COLLECTION TUBE W/ CLOT ACTIVATOR & GEL SEPARATOR
K960858 · Greiner America, Inc. · Aug 1996
VACUTAINER BRAND PLUS SERUM & SST TUBES
K960250 · Becton Dickinson Vacutainer Systems · Mar 1996
SUDORMED SWEAT PATCH SPECIMENT CONTAINER (PHENCYCLIDINE)
K936240 · Sudormed, Inc. · Mar 1996
PRO-VENT, LINE DRAW, PULSATOR
K952516 · Smiths Industries Medical Systems, Inc. · Jul 1995
MONOJECT(R) SAMPLETTE(R) COLLECTION TUBE
K944083 · Sherwood Medical Co. · May 1995
VACUTAINER BRAND SAFETY-LOK NEEDLE HOLDER
K950432 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1995