510(k) · Cleared
Recalled · Class II · 2025Greiner Vacuette Blood Collection Tube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Greiner America, Inc. · GIM Tubes, Vacuum Sample, With Anticoagulant
Cleared on May 2, 1997 after a 30-day review. The FDA summary names its predicate without a number. 1 later device descends from it. It has been recalled 7 times.
- Decided
- May 2, 1997
- Review
- 30 days
- Class
- Class II
- Product code
- GIM
- Recalls
- 7
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK971221 Greiner Vacuette Blood Collection TubeGreiner America, Inc. · 1997
- Descendant · cites it directly · 0 of its ownK992244 Greiner Minicollect Coagulation Blood Collection TubeGreiner Meditech, Inc. · 1999
Most influential descendants
Showing 1 of 1 · See all- K992244Greiner Minicollect Coagulation Blood Collection TubeGreiner Meditech, Inc. · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K971221 | Greiner Vacuette Blood Collection Tube | Greiner America, Inc. | 1997 | — |
| +1 | K992244 | Greiner Minicollect Coagulation Blood Collection Tube | Greiner Meditech, Inc. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
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 GIM? 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 GIM device
- #1 K240455 BD Vacutainer® Citrate Blood Collection Tubesscore 8.3 · 1 generation · 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 |
|---|---|---|---|
| * | — | Becton Dickinson's Vacutainer® sodium citrate tube Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K992244 | Greiner Minicollect Coagulation Blood Collection Tube | 1999 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 8, 2025 | Class II | Z-0408-2026 | Under Investigation by firm | Blood collection tubes were manufactured with the label applied too high on the tube, which shifted the printed fill level mark upward, which could result in unnecessary sample rejection and repeat collections. |
| Aug 20, 2021 | Class II | Z-2507-2021 | Under Investigation by firm | Complaint of tubes clotting due to variation of anticoagulant and/or tubes have low vacuum. |
| Mar 29, 2021 | Class II | Z-1534-2021 | Process control | VACUETTE¿ Blood Collection tube 9NC Coagulation sodium citrate 3.2% may show insufficient draw volume of the tubes, which could produce erroneous results for prothrombin time, activated partial thromboplastin time, and fibrinogen assays. |
| Mar 12, 2020 | Class II | Z-1714-2020 | Process change control | Concerned lot of VACETTE 2mL 9NC Coagulation Tubes were shown to have inconsistent amounts of the 2.3% sodium citrate. |
| Jul 2, 2012 | Class II | Z-2154-2012 | Nonconforming Material/Component | Part of the lot received a lower concentration of citrate solution which may cause falsely lower values for common coagulation tests. |
| Aug 2, 2006 | Not classified | Z-1498-06 | Other | Coagulation tubes found with no additive. |
| Jul 27, 2004 | Not classified | Z-1331-04 | Other | Coagulation tubes may not have received the proper fill of citrate solution. |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K992244 (Greiner Meditech, Inc., 1999) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GIM devicesGIM Tubes, Vacuum Sample, With Anticoagulant: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GIM
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · GIM
Too few GIM 510(k)s in any year since 2007 to give a median.
Recalls per year · GIM
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GIM
641in 2025
MAUDE reports naming product code GIM, 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 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 1 | 3 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 1 | — | 0 | 12 |
| 2018 | 0 | — | 0 | 276 |
| 2019 | 0 | — | 0 | 145 |
| 2020 | 0 | — | 0 | 147 |
| 2021 | 0 | — | 0 | 55 |
| 2022 | 0 | — | 0 | 42 |
| 2023 | 2 | — | 0 | 33 |
| 2024 | 1 | — | 0 | 316 |
| 2025 | 0 | — | 1 | 641 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Greiner Vacuette® blood collection tube with sodium citrate is an evacuated blood collection device containing sodium citrate anticoagulant additive and intended for use in evaluations of coagulation analyses.
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/K971221 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971221: Greiner Vacuette Blood Collection Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971221
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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