Cleared Traditional

K081229 - SAF-T CLOSED BLOOD COLLECTION SYSTEM WI...

K081229 is the FDA 510(k) clearance for SAF-T CLOSED BLOOD COLLECTION SYSTEM WI... by Smiths Medical Asd, Inc.. It is a Class 2 Chemistry device (product code JKA) cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K081229 · Smiths Medical Asd, Inc. · Chemistry device
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Optimized for regulatory review, auditing and printing
Jul 2008
Decision
82d
Days
Class 2
Risk

K081229 is an FDA 510(k) clearance for the SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH SAF-HOLDER DEVICE, WITH 21G, 23G, 2.... Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by Smiths Medical Asd, Inc. (Keene, US). The FDA issued a Cleared decision on July 21, 2008 after a review of 82 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 Smiths Medical Asd, Inc. devices

Submission Details

510(k) Number K081229 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2008
Decision Date July 21, 2008
Days to Decision 82 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 88d · This submission: 82d
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 Chemistry 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 K081229.
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K093972 · Becton, Dickinson & CO · Jan 2010
HEMOGLOBIN CAPILLARY COLLECTION SYSTEM (HCCS), 1 TEST, HEMOGLOBIN CAPILLARY COLLECTION SYSTEM (HCCS), 5 TESTS, HEMOGLOBI
K090737 · Bio-Rad Laboratories, Inc. · Jun 2009
SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH SAF-HOLDER DEVICE, MODEL 99200, SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH
K072783 · Smiths Medical Asd, Inc. · Nov 2007
VACU LAB PLAIN TUBE, VACU LAB GEL & CLOT ACTIVATOR TUBE, VACU LAB COAGULATION TUBE
K060364 · Teco Diagnostics · Jun 2006
CYTO-CHEX BCT
K040107 · Streck Laboratories, Inc. · Jul 2004