510(k) · Cleared
ClearedMiniCollect K2E K2EDTA Tubes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Greiner Bio-One Na, Inc. · JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Cleared on Jan 25, 2019 as substantially equivalent to K093972 (Becton, Dickinson & CO, 2010) after a 176-day review. Its family tree reaches back 2 generations to 1994.
- Decided
- Jan 25, 2019
- Review
- 176 days
- Class
- Class II
- Product code
- JKA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K940905 (1994). No later device cites it as a predicate yet.
- Root · 2 generations backK940905 Microtainer Brand Tube with Edta (K2)Bd Becton Dickinson Vacutainer Systems Preanalytic · 1994 · Recalled
- 1 generation backK093972 BD Microtainer Map Microtube for Automated Process, Model 363706Becton, Dickinson & CO · 2010 · Recalled
- This deviceK182078 MiniCollect K2E K2EDTA TubesGreiner Bio-One Na, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K940905 | Microtainer Brand Tube with Edta (K2) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1994 | 2 |
| −1 | K093972 | BD Microtainer Map Microtube for Automated Process, Model 363706 | Becton, Dickinson & CO | 2010 | 1 |
| 0 (this device) | K182078 | MiniCollect K2E K2EDTA Tubes | Greiner Bio-One Na, Inc. | 2019 | — |
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
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 | Decided |
|---|---|---|---|
| * | K093972 | BD Microtainer Map Microtube for Automated Process, Model 363706Summary page 4…ulation Medical Specialty: Clinical Chemistry 510k Review Panel: Hematology 3. PREDICATE DEVICE BD Microtainer® MAP Microtube for Automated Process (K093972) 4. DEVICE DESCRIPTION MiniCollect® Tubes are plastic, non-evacuated, non-sterile low sample volume tubes with integrated colle… | 2010 |
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?
- The line of descent spans 25 years and passes through 3 companies; a new generation was cleared every 15.5 years on median.
- 2 of the 2 ancestors have a recall of any class.
- 1 other device also cites its predicate K093972.
How does its category compare?
All JKA devicesJKA Tubes, Vials, Systems, Serum Separators, Blood Collection: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · JKA
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JKA
115in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JKA
13in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JKA
6,089in 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?
MiniCollect® K2E K2EDTA Tubes are non-evacuated blood collection devices, used to collect, transport, store, and
evaluate capillary blood specimens for the following hematology parameters: WBC, RBC, HGB, HCT, MCV, MCH,
MCHC, Platelets, RDW, Lymphocytes, Neutrophils, Monocytes, Eosinophils and Basophils.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182078 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182078: MiniCollect K2E K2EDTA Tubes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182078
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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