Cleared Traditional

K892665 - PRO-JECT(TM) SAFETY NEEDLE HOLDER

K892665 is an FDA 510(k) clearance for PRO-JECT(TM) SAFETY NEEDLE HOLDER, manufactured by Pro-Tec Containers, Inc.. The device is a Class 2 Chemistry device with product code JKA cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K892665 · Pro-Tec Containers, Inc. · Chemistry device
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Oct 1989
Decision
174d
Days
Class 2
Risk

K892665 is an FDA 510(k) clearance for the PRO-JECT(TM) SAFETY NEEDLE HOLDER. Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by Pro-Tec Containers, Inc. (Irvine, US). The FDA issued a Cleared decision on October 4, 1989 after a review of 174 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Pro-Tec Containers, Inc. devices

FDA 510(k) Submission Details - K892665

510(k) Number K892665 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 1989
Decision Date October 04, 1989
Days to Decision 174 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d slower than avg
Panel avg: 88d · This submission: 174d
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 171
Devices cleared under the same product code (JKA) and FDA review panel - the closest regulatory comparables to K892665.
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