510(k) · Cleared

Recalled · Class II · 2026

Greiner Vacuette Blood Collection Tube W/Lithium Heparin & Gel Separator

K960857510(k) TraditionalCleared Aug 30, 1996182-day reviewClass II21 CFR 862.1675Recalls 5

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 Aug 30, 1996 as substantially equivalent to K944566 (Bd Becton Dickinson Vacutainer Systems Preanalytic, 1994) after a 182-day review. Its family tree reaches back 1 generation to 1994. 1 later device descends from it. It has been recalled 5 times.

Decided: Aug 30, 1996
Review: 182 days
Class: Class II
Product code: JKA
Recalls: 5
Predicates: 1

Its longest line of descent runs back 1 generation to K944566 (1994). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK944566 Vacutainer Brand Plus Sodium Heparin TubeBd Becton Dickinson Vacutainer Systems Preanalytic · 1994 · Recalled
This deviceK960857 Greiner Vacuette Blood Collection Tube W/Lithium Heparin & Gel…Greiner America, Inc. · 1996
Descendant · cites it directly · 0 of its ownK011699 Vacuette Evacuated Blood Collection TubesGreiner Bio-One Vacuette North America · 2001

Most influential descendants

Showing 1 of 1 · See all

K011699Vacuette Evacuated Blood Collection TubesGreiner Bio-One Vacuette North America · 2001 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K944566	Vacutainer Brand Plus Sodium Heparin Tube	Bd Becton Dickinson Vacutainer Systems Preanalytic	1994	2
0 (this device)	K960857	Greiner Vacuette Blood Collection Tube W/Lithium Heparin & Gel Separator	Greiner America, Inc.	1996	—
+1	K011699	Vacuette Evacuated Blood Collection Tubes	Greiner Bio-One Vacuette North America	2001	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0

FIG. 1 — Lineage of K960857, 1994–2001Source: 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
*	K944566	Vacutainer Brand Plus Sodium Heparin Tube Summary page 1 …g blood plasma from the cellular components of blood. Greiner is claiming substantial equivalence to Becton Dickinson's Vacutainer® brand lithium heparin additive tube (K944566). Both blood collection tubes have the same intended use and contain the same stopper material, additive and separator. The tube…	Bd Becton Dickinson Vacutainer Systems Preanalytic	1994	2

Also cleared against K944566: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K011699	Vacuette Evacuated Blood Collection Tubes	Greiner Bio-One Vacuette North America	2001	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jul 29, 2026	Class II	Z-0200-2027	Nonconforming Material/Component	Lot B26043FM may include EDTA contamination which introduces potassium while chelating calcium in patient samples, leading to falsely elevated potassium (K+) and falsely decreased calcium (Ca++) results which have the potential to cause…
Dec 9, 2021	Class II	Z-0502-2022	Under Investigation by firm	Some of the blood collection tubes show clotting due to variation of Lithium Heparin.
Dec 14, 2011	Not classified	Z-1081-2012	Material/Component Contamination	The lithium heparin tubes may have a contamination with EDTA potassium.
Aug 25, 2010	Not classified	Z-0623-2011	Other	Lithium heparin solution was contaminated by EDTA K (potassium) solution due to an operator error and a misinterpretation of a test result. Contaminated tubes will produce inaccurate test results.
Jul 29, 2008	Not classified	Z-0215-2009	Labeling mix-ups	Labeling Error: Incorrect tube label reads "Z Serum Clot Activator" instead of "LH Lithium Heparin" tube. All other information on the tube label including color coding of tube was correct. Case and rack label information showed the…

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has a recall.
Of its descendants, K011699 (Greiner Bio-One Vacuette North America, 2001) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K944566.

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 product is intended for use in holding and separating blood plasma from the cellular components of blood.

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/K960857 · printed Nov 4, 2026

Cite this page

510(k) Report. “K960857: Greiner Vacuette Blood Collection Tube W/Lithium Heparin & Gel Separator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K960857

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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