510(k) · Cleared

Recalled · Class II · 2023

Greiner Vacuette Blood Collection Tube E/Edta K3

K960860510(k) TraditionalCleared Sep 5, 1996188-day reviewClass II21 CFR 862.1675Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Greiner America, Inc. · JKA Tubes, Vials, Systems, Serum Separators, Blood Collection

Cleared on Sep 5, 1996 as substantially equivalent to K940905 (Bd Becton Dickinson Vacutainer Systems Preanalytic, 1994) after a 188-day review. Its family tree reaches back 1 generation to 1994. It has been recalled once.

Decided: Sep 5, 1996
Review: 188 days
Class: Class II
Product code: JKA
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K940905 (1994). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK940905 Microtainer Brand Tube with Edta (K2)Bd Becton Dickinson Vacutainer Systems Preanalytic · 1994 · Recalled
This deviceK960860 Greiner Vacuette Blood Collection Tube E/Edta K3Greiner America, Inc. · 1996

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K940905	Microtainer Brand Tube with Edta (K2)	Bd Becton Dickinson Vacutainer Systems Preanalytic	1994	2
0 (this device)	K960860	Greiner Vacuette Blood Collection Tube E/Edta K3	Greiner America, Inc.	1996	—

FIG. 1 — Lineage of K960860, 1994–1996Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in JKA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new JKA device

#1 K200027 Blood Collection Needle with/without Holder…score 15.6 · 3 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K940905	Microtainer Brand Tube with Edta (K2) Summary page 1 …and intended for use in evaluations of whole blood specimens. Greiner is claiming substantial equivalence to Becton Dickinson's Vacutainer® brand EDTA K, additive tube (K940905). Both blood collection tubes have the same intended use and contain the same stopper material and additive. The tube material fo…	Bd Becton Dickinson Vacutainer Systems Preanalytic	1994	2

Also cleared against K940905: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Mar 31, 2023	Class II	Z-1583-2023	Labeling Change Control	Some of the tubes may be incorrectly labeled.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has a recall.
3 other devices also cite its predicate K940905.

How does its category compare?

All JKA devices

JKA Tubes, Vials, Systems, Serum Separators, Blood Collection: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JKA

7in 2025

2007high 17 (2023) · low 0 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JKA

115in 2025

2007high 281 (2007) · low 28 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JKA

13in 2025

2007high 14 (2011) · low 0 (2020)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JKA

6,089in 2025

2007high 9,731 (2018) · low 33 (2013)2025

MAUDE reports naming product code JKA, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	4	281	3	73
2008	2	—	3	78
2009	2	—	3	42
2010	4	28	4	37
2011	0	—	14	67
2012	1	—	2	54
2013	3	244	1	33
2014	1	—	1	68
2015	1	—	6	41
2016	4	116	1	65
2017	2	—	2	2,039
2018	1	—	2	9,731
2019	6	181	9	6,469
2020	6	181	0	3,774
2021	4	217	3	3,610
2022	9	164	2	3,375
2023	17	189	2	4,400
2024	6	240	0	4,609
2025	7	115	13	6,089
2026	8	250	1	—

What is it indicated for?

The Greiner Vacuette™ blood collection tube with EDTA K3 is an evacuated blood collection device containing EDTA K3 anticoagulant additive and intended for use in evaluations of whole blood specimens.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K960860 · printed Nov 4, 2026

Cite this page

510(k) Report. “K960860: Greiner Vacuette Blood Collection Tube E/Edta K3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K960860

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026