Cleared Traditional

K914129 - DIFF SAFE

K914129 is an FDA 510(k) clearance for DIFF SAFE, manufactured by Marshall Levinson. The device is a Class 2 Chemistry device with product code JKA cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K914129 · Marshall Levinson · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1991
Decision
28d
Days
Class 2
Risk

K914129 is an FDA 510(k) clearance for the DIFF SAFE. Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by Marshall Levinson (Wayne, US). The FDA issued a Cleared decision on October 11, 1991 after a review of 28 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 Marshall Levinson devices

FDA 510(k) Submission Details - K914129

510(k) Number K914129 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 1991
Decision Date October 11, 1991
Days to Decision 28 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 88d · This submission: 28d
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 K914129.
VACUTAINER BRAND LUER ADAPTER
K921520 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1992
VACUTAINER(R) BRAND SST(R) AND CAT TUBES
K921806 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1992
QBC E-Z PREP
K913399 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1991
NEW-VENT
K911809 · Concord/Portex · Aug 1991
SYRINGE TIP CAP
K911638 · Concord/Portex · Jun 1991
SUPERSERUM REAGENT (SSR)
K910646 · International Technidyne Corp. · May 1991