Cleared Traditional

K945245 - BLOOD KIT, SEXUAL ASSAULT KIT

K945245 is an FDA 510(k) clearance for BLOOD KIT, manufactured by Lynn Peavey Co.. The device is a Class 2 Toxicology device with product code JKA cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K945245 · Lynn Peavey Co. · Toxicology device
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Feb 1995
Decision
97d
Days
Class 2
Risk

K945245 is an FDA 510(k) clearance for the BLOOD KIT, SEXUAL ASSAULT KIT. Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by Lynn Peavey Co. (Lenexa, US). The FDA issued a Cleared decision on February 1, 1995 after a review of 97 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.1675 - the FDA toxicology device 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 Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Lynn Peavey Co. devices

FDA 510(k) Submission Details - K945245

510(k) Number K945245 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 1994
Decision Date February 01, 1995
Days to Decision 97 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 87d · This submission: 97d
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 Toxicology devices follow this clearance model.

Regulatory Peers - JKA Tubes, Vials, Systems, Serum Separators, Blood Collection

All 169
Devices cleared under the same product code (JKA) and FDA review panel - the closest regulatory comparables to K945245.
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
VACUTAINER(R) BRAND PLUS PST(TM) PLASMA SEPARATION TUBE
K945952 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1995
PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES
K945777 · Smiths Industries Medical Systems, Inc. · Dec 1994
CLARIT(TM)
K945353 · Advanced Biomedical Methods, Inc. · Dec 1994