Cleared Traditional

K890109 - SAFEPETTE DISPENSER

K890109 is the FDA 510(k) clearance for SAFEPETTE DISPENSER by Safe-Tec Clinical Products, Inc.. It is a Class 2 Chemistry device (product code JKA) cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K890109 · Safe-Tec Clinical Products, Inc. · Chemistry device
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Feb 1989
Decision
44d
Days
Class 2
Risk

K890109 is an FDA 510(k) clearance for the SAFEPETTE DISPENSER. Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by Safe-Tec Clinical Products, Inc. (Ivyland, US). The FDA issued a Cleared decision on February 23, 1989 after a review of 44 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 Safe-Tec Clinical Products, Inc. devices

Submission Details

510(k) Number K890109 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 1989
Decision Date February 23, 1989
Days to Decision 44 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 88d · This submission: 44d
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 116
Devices cleared under the same product code (JKA) and FDA review panel - the closest regulatory comparables to K890109.
SUPERSERUM REAGENT (SSR)
K910646 · International Technidyne Corp. · May 1991
VACUTAINER PLUS WITH HEMOGARD CLOSURE
K901449 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1990
VENOJECT II BLOOD COLLECTION TUBES
K900309 · Terumo Medical Corp. · Mar 1990
PUMPETTE(TM)
K884111 · Helena Laboratories · Dec 1988
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