510(k) · Cleared
ClearedVacutainer (R) Brand Safety-Lok Blood Collect Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bd Becton Dickinson Vacutainer Systems Preanalytic · GIM Tubes, Vacuum Sample, With Anticoagulant
Cleared on Apr 29, 1992 after a 23-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 24 later devices descend from it.
- Decided
- Apr 29, 1992
- Review
- 23 days
- Class
- Class II
- Product code
- GIM
- Recalls
- None
- Predicates
- 0
24 later devices descend from it, 1 citing it directly.
- This deviceK921636 Vacutainer (R) Brand Safety-Lok Blood Collect SetBd Becton Dickinson Vacutainer Systems Preanalytic · 1992
- Descendant · cites it directly · 23 of its ownK011984 BD Vacutainer Push Button Blood Colection SetBecton, Dickinson & CO · 2001 · Recalled
- Descendant · 2 generations on · 18 of its ownK022875 Modification to BD Vacutainer Push Button Blood Collection SetBecton, Dickinson & CO · 2002
- Descendant · 3 generations on · 17 of its ownK030573 BD Vacutainer Push Button Blood Collection Set, Models 367338…Bd Vacutainer Systems Preanalyical Solutions · 2003 · Recalled
- Descendant · 4 generations on · 6 of its ownK153309 BD Vacutainer UltraTouch Push Button Blood Collection SetBecton, Dickinson and Company · 2016
- Descendant · 4 generations on · 5 of its ownK192247 Steripath Gen2 Blood Collection SystemMagnolia Medical Technologies, Inc. · 2020 · Recalled
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K011984BD Vacutainer Push Button Blood Colection SetBecton, Dickinson & CO · 2001 · cites it directly23descendants
- K022875Modification to BD Vacutainer Push Button Blood Collection SetBecton, Dickinson & CO · 2002 · 2 generations on18descendants
- K030573BD Vacutainer Push Button Blood Collection Set, Models 367338, 367344, 367336, 367342…Bd Vacutainer Systems Preanalyical Solutions · 2003 · 3 generations on17descendants
- K153309BD Vacutainer UltraTouch Push Button Blood Collection SetBecton, Dickinson and Company · 2016 · 4 generations on6descendants
- K192247Steripath Gen2 Blood Collection SystemMagnolia Medical Technologies, Inc. · 2020 · 4 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K921636 | Vacutainer (R) Brand Safety-Lok Blood Collect Set | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1992 | — |
| +1 | K011984 | BD Vacutainer Push Button Blood Colection Set | Becton, Dickinson & CO | 2001 | 7 |
| +2 | K022875 | Modification to BD Vacutainer Push Button Blood Collection Set | Becton, Dickinson & CO | 2002 | — |
| +3 | K030573 | BD Vacutainer Push Button Blood Collection Set, Models 367338, 367344, 367336… | Bd Vacutainer Systems Preanalyical Solutions | 2003 | 5 |
| +4 | K153309 | BD Vacutainer UltraTouch Push Button Blood Collection Set | Becton, Dickinson and Company | 2016 | — |
| +4 | K192247 | Steripath Gen2 Blood Collection System | Magnolia Medical Technologies, Inc. | 2020 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 5 | 0 |
| 2023 | 6 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (24)
See all 241 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K011984 | BD Vacutainer Push Button Blood Colection Set | 2001 | 23 |
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?
- Of its descendants, K011984 (Becton, Dickinson & CO, 2001) has gone furthest, with 23 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 | — |
https://510kreport.com/device/K921636 · printed Nov 6, 2026
Cite this page
510(k) Report. “K921636: Vacutainer (R) Brand Safety-Lok Blood Collect Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K921636
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026