510(k) · Cleared
Recalled · Class II · 2019BD Vacutainer Push Button Blood Colection Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton, Dickinson & CO · FMI Needle, Hypodermic, Single Lumen
Cleared on Aug 29, 2001 as substantially equivalent to K921636 (Bd Becton Dickinson Vacutainer Systems Preanalytic, 1992) and 3 other predicates after a 64-day review. Its family tree reaches back 2 generations to 1997. 23 later devices descend from it. It has been recalled 7 times.
- Decided
- Aug 29, 2001
- Review
- 64 days
- Class
- Class II
- Product code
- FMI
- Recalls
- 7
- Predicates
- 4
Its longest line of descent runs back 2 generations to K970259 (1997). 5 ancestors in all, the oldest K921636 (1992). 23 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK970259 E-Z Set Infusion Set/Saf-T E-Z Set Infusion SetBecton Dickinson Vascular Access, Inc. · 1997
- 1 generation backK980414 Vacutainer Brand Safety-Lok Blood Collection Set Model Multiple…Bd Becton Dickinson Vacutainer Systems Preanalytic · 1998 · Recalled
- This deviceK011984 BD Vacutainer Push Button Blood Colection SetBecton, Dickinson & CO · 2001
- Descendant · cites it directly · 18 of its ownK022875 Modification to BD Vacutainer Push Button Blood Collection SetBecton, Dickinson & CO · 2002
- Descendant · 2 generations on · 17 of its ownK030573 BD Vacutainer Push Button Blood Collection Set, Models 367338…Bd Vacutainer Systems Preanalyical Solutions · 2003 · Recalled
- Descendant · 3 generations on · 6 of its ownK153309 BD Vacutainer UltraTouch Push Button Blood Collection SetBecton, Dickinson and Company · 2016
- Descendant · 3 generations on · 5 of its ownK192247 Steripath Gen2 Blood Collection SystemMagnolia Medical Technologies, Inc. · 2020 · Recalled
- Descendant · 4 generations on · 2 of its ownK213718 SOL-GUARD Safety Pull Button Collection SetSol-Millennium Medical, Inc. · 2022
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K022875Modification to BD Vacutainer Push Button Blood Collection SetBecton, Dickinson & CO · 2002 · cites it directly18descendants
- K030573BD Vacutainer Push Button Blood Collection Set, Models 367338, 367344, 367336, 367342…Bd Vacutainer Systems Preanalyical Solutions · 2003 · 2 generations on17descendants
- K153309BD Vacutainer UltraTouch Push Button Blood Collection SetBecton, Dickinson and Company · 2016 · 3 generations on6descendants
- K192247Steripath Gen2 Blood Collection SystemMagnolia Medical Technologies, Inc. · 2020 · 3 generations on5descendants
- K213718SOL-GUARD Safety Pull Button Collection SetSol-Millennium Medical, Inc. · 2022 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K970259 | E-Z Set Infusion Set/Saf-T E-Z Set Infusion Set | Becton Dickinson Vascular Access, Inc. | 1997 | — |
| −1 | K980414 | Vacutainer Brand Safety-Lok Blood Collection Set Model Multiple, Vacutainer… | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1998 | 1 |
| 0 (this device) | K011984 | BD Vacutainer Push Button Blood Colection Set | Becton, Dickinson & CO | 2001 | — |
| +1 | K022875 | Modification to BD Vacutainer Push Button Blood Collection Set | Becton, Dickinson & CO | 2002 | — |
| +2 | K030573 | BD Vacutainer Push Button Blood Collection Set, Models 367338, 367344, 367336… | Bd Vacutainer Systems Preanalyical Solutions | 2003 | 5 |
| +3 | K153309 | BD Vacutainer UltraTouch Push Button Blood Collection Set | Becton, Dickinson and Company | 2016 | — |
| +3 | K192247 | Steripath Gen2 Blood Collection System | Magnolia Medical Technologies, Inc. | 2020 | 2 |
| +4 | K213718 | SOL-GUARD Safety Pull Button Collection Set | Sol-Millennium Medical, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), 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 FMI? 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 FMI device
- #1 K252886 Pen Needlescore 14.5 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K921636 | Vacutainer (R) Brand Safety-Lok Blood Collect SetSummary page 3…evices, K number, and clearance date are also identified in the table below. Clearance Date Manufacturer Predicate Device K-Number Becton Dickinson | BD VACUTAINER™ | K921636 April 29, 1992 Brand Safety-Lok™ K931367 May 18, 1993 Blood Collection Set | K965202 February 10, 1997 K980414 March 3, 1998 J]%… | 1992 |
| * | K931367 | Vacutainer Brand Luer AdapterSummary page 3…also identified in the table below. Clearance Date Manufacturer Predicate Device K-Number Becton Dickinson | BD VACUTAINER™ | K921636 April 29, 1992 Brand Safety-Lok™ K931367 May 18, 1993 Blood Collection Set | K965202 February 10, 1997 K980414 March 3, 1998 J]% %’ fiL@M VgAIE ot 17 200/ M. Wendy Bo rat… | 1993 |
| * | K965202 | Vacutainer Brand Safety-Lok Blood Collection SetSummary page 3…nce Date Manufacturer Predicate Device K-Number Becton Dickinson | BD VACUTAINER™ | K921636 April 29, 1992 Brand Safety-Lok™ K931367 May 18, 1993 Blood Collection Set | K965202 February 10, 1997 K980414 March 3, 1998 J]% %’ fiL@M VgAIE ot 17 200/ M. Wendy Bo rat Dat Regulatory Affairs Specialist Becton Di… | 1997 |
| * | K980414 | Vacutainer Brand Safety-Lok Blood Collection Set Model Multiple, Vacutainer Brand Blood…Summary page 3…dicate Device K-Number Becton Dickinson | BD VACUTAINER™ | K921636 April 29, 1992 Brand Safety-Lok™ K931367 May 18, 1993 Blood Collection Set | K965202 February 10, 1997 K980414 March 3, 1998 J]% %’ fiL@M VgAIE ot 17 200/ M. Wendy Bo rat Dat Regulatory Affairs Specialist Becton Dickinson VACUTAINER Systems… | 1998 |
What descends from it? (23)
See all 233 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 31, 2019 | Class II | Z-0193-2020 | Under Investigation by firm | Separation of front and rear barrels upon activation of the safety feature that retracts the needle |
| Oct 5, 2010 | Not classified | Z-0816-2011 | Process control | There is the possibility for certain lots of the BD Vacutainer Push Button Blood Collection sets to have separation of the cannula from the hub. |
| Nov 20, 2007 | Not classified | Z-0589-2008 | Material/Component Contamination | Safety Mechanism Failure: the safety mechanism of the BD Vacutainer Push Button Collection Set with Pre-attached holder cannot be activated; thus the needle cannot retract into the rear barrel. |
| Nov 20, 2007 | Not classified | Z-0590-2008 | Material/Component Contamination | Safety Mechanism Failure: the safety mechanism of the BD Vacutainer Push Button Collection Set with Pre-attached holder cannot be activated; thus the needle cannot retract into the rear barrel. |
| Aug 11, 2006 | Not classified | Z-0034-2007 | Other | A complaint was received regarding a BD blood collection set where the blister was noticeably warped. The seal width was below minimum specification. Some blisters could adhere together and crack upon separation. Some units may have… |
| Dec 1, 2005 | Not classified | Z-0372-06 | Other | Cracked finger grip luer adapter components on the Push Button Blood Collection Set. |
| Dec 17, 2003 | Not classified | Z-0549-04 | Other | A hole was noticed in the 'blister pack' that is used to package the device and provides the sterility barrier. Sterility could be compromised. |
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?
- The line of descent spans 4 years and passes through 3 companies; a new generation was cleared every 3.5 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K022875 (Becton, Dickinson & CO, 2002) has gone furthest, with 18 descendants of its own.
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FMI
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMI
141in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FMI
1in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · FMI
2,424in 2025
MAUDE reports naming product code FMI, 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 | 15 | 71 | 2 | 208 |
| 2008 | 10 | 85 | 4 | 177 |
| 2009 | 7 | 177 | 3 | 263 |
| 2010 | 15 | 119 | 79 | 249 |
| 2011 | 12 | 113 | 5 | 240 |
| 2012 | 17 | 107 | 1 | 215 |
| 2013 | 11 | 87 | 1 | 255 |
| 2014 | 14 | 155 | 3 | 287 |
| 2015 | 10 | 89 | 1 | 567 |
| 2016 | 20 | 217 | 0 | 941 |
| 2017 | 9 | 253 | 16 | 1,547 |
| 2018 | 20 | 176 | 0 | 2,398 |
| 2019 | 12 | 186 | 5 | 4,896 |
| 2020 | 11 | 263 | 3 | 4,245 |
| 2021 | 18 | 143 | 7 | 4,532 |
| 2022 | 23 | 189 | 0 | 4,885 |
| 2023 | 18 | 112 | 2 | 4,986 |
| 2024 | 3 | 90 | 1 | 4,053 |
| 2025 | 11 | 141 | 0 | 2,424 |
| 2026 | 12 | 119 | 1 (1) | — |
What is it indicated for?
The BD VACUTAINER™ Push Button Blood Collection Set is a sterile, multiple-sample, single-use winged blood collection set intended for venipuncture to obtain blood specimens from patients. The recommended use of the device is to activate the needle prior to removal from the venipuncture site. The retraction of the intravenous (IV) end of the needle aids in the prevention of needlestick injury.
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/K011984 · printed Nov 4, 2026
Cite this page
510(k) Report. “K011984: BD Vacutainer Push Button Blood Colection Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011984
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026