Cleared Traditional

K002777 - VACUETTE WITH PPACK

K002777 is an FDA 510(k) clearance for VACUETTE WITH PPACK, manufactured by Greiner Vacuette North America, Inc.. The device is a Class 2 Chemistry device with product code JKA cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K002777 · Greiner Vacuette North America, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2000
Decision
29d
Days
Class 2
Risk

K002777 is an FDA 510(k) clearance for the VACUETTE WITH PPACK. Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by Greiner Vacuette North America, Inc. (Ellicott City, US). The FDA issued a Cleared decision on October 5, 2000 after a review of 29 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 Greiner Vacuette North America, Inc. devices

FDA 510(k) Submission Details - K002777

510(k) Number K002777 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2000
Decision Date October 05, 2000
Days to Decision 29 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
59d faster than avg
Panel avg: 88d · This submission: 29d
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 161
Devices cleared under the same product code (JKA) and FDA review panel - the closest regulatory comparables to K002777.
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K991702 · Becton Dickinson Vacutainer Systems · Jul 1999