510(k) · Cleared

Cleared

Greiner Minicollect Edta Blood Collection Tube

K982999510(k) TraditionalCleared Oct 16, 199850-day reviewClass II21 CFR 862.1675

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

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

Cleared on Oct 16, 1998 as substantially equivalent to K940905 (Bd Becton Dickinson Vacutainer Systems Preanalytic, 1994) after a 50-day review. Its family tree reaches back 1 generation to 1994.

Decided: Oct 16, 1998
Review: 50 days
Class: Class II
Product code: JKA
Recalls: None
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 deviceK982999 Greiner Minicollect Edta Blood Collection TubeGreiner Meditech, Inc. · 1998

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)	K982999	Greiner Minicollect Edta Blood Collection Tube	Greiner Meditech, Inc.	1998	—

FIG. 1 — Lineage of K982999, 1994–1998Source: 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 …itive, and is intended for use in evaluations of capillary blood specimens. Greiner is claiming substantial equivalence to Becton Dickinson’s Microtainer® EDTA K tube (K940905). Both blood collection tubes have the same intended use and are made out of the same material, polypropylene plastic. The Becton…	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)

No FDA recall names this device.

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?

To collect, transport, store, and evaluate capillary blood specimens for hematology and lead tests.

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/K982999 · printed Nov 5, 2026

Cite this page

510(k) Report. “K982999: Greiner Minicollect Edta Blood Collection Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K982999

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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