Cleared Traditional

JJ SKINNER CAREKITS(TM) BLOOD COLLECTION KIT (K925468) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K925468 · J.J. Skinner, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1994
Decision
529d
Days
Class 2
Risk

K925468 is an FDA 510(k) clearance for the JJ SKINNER CAREKITS(TM) BLOOD COLLECTION KIT. Classified as Tray, Blood Collection (product code GJE), Class II - Special Controls.

Submitted by J.J. Skinner, Inc. (Great Neck, US). The FDA issued a Cleared decision on April 11, 1994 after a review of 529 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all J.J. Skinner, Inc. devices

Submission Details

510(k) Number K925468 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received October 29, 1992
Decision Date April 11, 1994
Days to Decision 529 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
441d slower than avg
Panel avg: 88d · This submission: 529d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GJE Tray, 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.