510(k) · Cleared
ClearedBD Vacutainer UltraTouch Push Button Blood Collection Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton, Dickinson and Company · JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Cleared on Feb 12, 2016 as substantially equivalent to K030573 (Bd Vacutainer Systems Preanalyical Solutions, 2003) after an 87-day review. Its family tree reaches back 5 generations to 1997. 6 later devices descend from it.
- Decided
- Feb 12, 2016
- Review
- 87 days
- Class
- Class II
- Product code
- JKA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K970259 (1997). 8 ancestors in all, the oldest K921636 (1992). 6 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK970259 E-Z Set Infusion Set/Saf-T E-Z Set Infusion SetBecton Dickinson Vascular Access, Inc. · 1997
- 4 generations backK980414 Vacutainer Brand Safety-Lok Blood Collection Set Model Multiple…Bd Becton Dickinson Vacutainer Systems Preanalytic · 1998 · Recalled
- 3 generations backK011984 BD Vacutainer Push Button Blood Colection SetBecton, Dickinson & CO · 2001 · Recalled
- 2 generations backK022875 Modification to BD Vacutainer Push Button Blood Collection SetBecton, Dickinson & CO · 2002
- 1 generation backK030573 BD Vacutainer Push Button Blood Collection Set, Models 367338…Bd Vacutainer Systems Preanalyical Solutions · 2003 · Recalled
- This deviceK153309 BD Vacutainer UltraTouch Push Button Blood Collection SetBecton, Dickinson and Company · 2016
- Descendant · cites it directly · 2 of its ownK213718 SOL-GUARD Safety Pull Button Collection SetSol-Millennium Medical, Inc. · 2022
- Descendant · cites it directly · 1 of its ownK212724 BD Vacutainer UltraTouch Push Button Blood Collection SetBecton, Dickinson and Company · 2022
- Descendant · 2 generations on · 0 of its ownK250907 Sol-Guard TM XtraThin Safety Pull-Button Blood Collection SetSol-Millennium Medical, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK232308 Monarch Blood Collection SetThe Monarch Company · 2023
- Descendant · 2 generations on · 0 of its ownK223854 Unistik® ShieldLock, Unistik VacuFlipOwen Mumford, Ltd. · 2023
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K213718SOL-GUARD Safety Pull Button Collection SetSol-Millennium Medical, Inc. · 2022 · cites it directly2descendants
- K212724BD Vacutainer UltraTouch Push Button Blood Collection SetBecton, Dickinson and Company · 2022 · cites it directly1descendant
- K250907Sol-Guard TM XtraThin Safety Pull-Button Blood Collection SetSol-Millennium Medical, Inc. · 2025 · 2 generations on0descendants
- K232308Monarch Blood Collection SetThe Monarch Company · 2023 · 2 generations on0descendants
- K223854Unistik® ShieldLock, Unistik VacuFlipOwen Mumford, Ltd. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K970259 | E-Z Set Infusion Set/Saf-T E-Z Set Infusion Set | Becton Dickinson Vascular Access, Inc. | 1997 | — |
| −4 | K980414 | Vacutainer Brand Safety-Lok Blood Collection Set Model Multiple, Vacutainer… | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1998 | 1 |
| −3 | 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 | — |
| −1 | K030573 | BD Vacutainer Push Button Blood Collection Set, Models 367338, 367344, 367336… | Bd Vacutainer Systems Preanalyical Solutions | 2003 | 5 |
| 0 (this device) | K153309 | BD Vacutainer UltraTouch Push Button Blood Collection Set | Becton, Dickinson and Company | 2016 | — |
| +1 | K213718 | SOL-GUARD Safety Pull Button Collection Set | Sol-Millennium Medical, Inc. | 2022 | — |
| +1 | K212724 | BD Vacutainer UltraTouch Push Button Blood Collection Set | Becton, Dickinson and Company | 2022 | — |
| +2 | K250907 | Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set | Sol-Millennium Medical, Inc. | 2025 | — |
| +2 | K232308 | Monarch Blood Collection Set | The Monarch Company | 2023 | — |
| +2 | K223854 | Unistik® ShieldLock, Unistik VacuFlip | Owen Mumford, Ltd. | 2023 | — |
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 |
|---|---|---|
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2025 | 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 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 |
|---|---|---|---|
| * | K030573 | BD Vacutainer Push Button Blood Collection Set, Models 367338, 367344, 367336, 367342…Summary page 4…ification: Class II, 21 CFR 862.1675 Product Code: JKA and FPA 3. Predicate Device: BD Vacutainer® Push Button Blood Collection Set – K030573 Manufactured by: Becton, Dickinson and Company 4. Device Description: The BD Vacutainer® Push Button Blood Collecti… | 2003 |
What descends from it? (6)
3 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)
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 19 years and passes through 5 companies; a new generation was cleared every 1.0 years on median.
- 3 of the 8 ancestors have a recall of any class.
- Of its descendants, K213718 (Sol-Millennium Medical, Inc., 2022) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K030573.
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. 2016, 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?
The BD Vacutainer® UltraTouch™ Push Button Blood Collection Set is a sterile, multiple sample, single-use fixed winged blood collection set intended for venipuncture to obtain blood specimens from patients. When used without the male adapter, the device allows the clinician to obtain blood sampling to the female hub with a syringe, if necessary, or can be used for short-term, single infusions with consideration given to patient size and appropriateness…
Read the full statement (130 words)
The BD Vacutainer® UltraTouch™ Push Button Blood Collection Set is a sterile, multiple sample, single-use fixed winged blood collection set intended for venipuncture to obtain blood specimens from patients. When used without the male adapter, the device allows the clinician to obtain blood sampling to the female hub with a syringe, if necessary, or can be used for short-term, single infusions with consideration given to patient size and appropriateness for the solution being infused. The device is not to be left in place and remain under the direct supervision of a clinician.
The recommended use of the device is to activate the needle safety feature prior to removal from the venipuncture site. The retraction of the intravenous (IV) end of the needle aids in the prevention of accidental 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/K153309 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153309: BD Vacutainer UltraTouch Push Button Blood Collection Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153309
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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