510(k) · Cleared
Recalled · Class II · 2018BD Vacutainer Push Button Blood Collection Set, Models 367338, 367344, 367336, 367342, 367335, 367341
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bd Vacutainer Systems Preanalyical Solutions · JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Cleared on May 8, 2003 as substantially equivalent to K980414 (Bd Becton Dickinson Vacutainer Systems Preanalytic, 1998) and 1 other predicate after a 73-day review. Its family tree reaches back 4 generations to 1997. 17 later devices descend from it. It has been recalled 5 times.
- Decided
- May 8, 2003
- Review
- 73 days
- Class
- Class II
- Product code
- JKA
- Recalls
- 5
- Predicates
- 2
Its longest line of descent runs back 4 generations to K970259 (1997). 7 ancestors in all, the oldest K921636 (1992). 17 later devices descend from it, 5 citing it directly.
- Root · 4 generations backK970259 E-Z Set Infusion Set/Saf-T E-Z Set Infusion SetBecton Dickinson Vascular Access, Inc. · 1997
- 3 generations backK980414 Vacutainer Brand Safety-Lok Blood Collection Set Model Multiple…Bd Becton Dickinson Vacutainer Systems Preanalytic · 1998 · Recalled
- 2 generations backK011984 BD Vacutainer Push Button Blood Colection SetBecton, Dickinson & CO · 2001 · Recalled
- 1 generation backK022875 Modification to BD Vacutainer Push Button Blood Collection SetBecton, Dickinson & CO · 2002
- This deviceK030573 BD Vacutainer Push Button Blood Collection Set, Models 367338…Bd Vacutainer Systems Preanalyical Solutions · 2003
- Descendant · cites it directly · 6 of its ownK153309 BD Vacutainer UltraTouch Push Button Blood Collection SetBecton, Dickinson and Company · 2016
- Descendant · cites it directly · 5 of its ownK192247 Steripath Gen2 Blood Collection SystemMagnolia Medical Technologies, Inc. · 2020 · Recalled
- Descendant · 2 generations on · 2 of its ownK213718 SOL-GUARD Safety Pull Button Collection SetSol-Millennium Medical, Inc. · 2022
- Descendant · 2 generations on · 2 of its ownK200661 Steripath Micro Blood Collection SystemMagnolia Medical Technologies, Inc. · 2020
- Descendant · cites it directly · 1 of its ownK220212 BD Vacutainer® Push Button Blood Collection Set, BD Vacutainer® Push…Becton, Dickinson and Company · 2023
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K153309BD Vacutainer UltraTouch Push Button Blood Collection SetBecton, Dickinson and Company · 2016 · cites it directly6descendants
- K192247Steripath Gen2 Blood Collection SystemMagnolia Medical Technologies, Inc. · 2020 · cites it directly5descendants
- K213718SOL-GUARD Safety Pull Button Collection SetSol-Millennium Medical, Inc. · 2022 · 2 generations on2descendants
- K200661Steripath Micro Blood Collection SystemMagnolia Medical Technologies, Inc. · 2020 · 2 generations on2descendants
- K220212BD Vacutainer® Push Button Blood Collection Set, BD Vacutainer® Push Button Blood…Becton, Dickinson and Company · 2023 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K970259 | E-Z Set Infusion Set/Saf-T E-Z Set Infusion Set | Becton Dickinson Vascular Access, Inc. | 1997 | — |
| −3 | K980414 | Vacutainer Brand Safety-Lok Blood Collection Set Model Multiple, Vacutainer… | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1998 | 1 |
| −2 | K011984 | BD Vacutainer Push Button Blood Colection Set | Becton, Dickinson & CO | 2001 | 7 |
| −1 | K022875 | Modification to BD Vacutainer Push Button Blood Collection Set | Becton, Dickinson & CO | 2002 | — |
| 0 (this device) | K030573 | BD Vacutainer Push Button Blood Collection Set, Models 367338, 367344, 367336… | Bd Vacutainer Systems Preanalyical Solutions | 2003 | — |
| +1 | K153309 | BD Vacutainer UltraTouch Push Button Blood Collection Set | Becton, Dickinson and Company | 2016 | — |
| +1 | K192247 | Steripath Gen2 Blood Collection System | Magnolia Medical Technologies, Inc. | 2020 | 2 |
| +2 | K213718 | SOL-GUARD Safety Pull Button Collection Set | Sol-Millennium Medical, Inc. | 2022 | — |
| +2 | K200661 | Steripath Micro Blood Collection System | Magnolia Medical Technologies, Inc. | 2020 | — |
| +1 | K220212 | BD Vacutainer® Push Button Blood Collection Set, BD Vacutainer® Push Button… | Becton, Dickinson and Company | 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 |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 5 | 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 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? (2)
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 |
|---|---|---|---|
| * | K980414 | Vacutainer Brand Safety-Lok Blood Collection Set Model Multiple, Vacutainer Brand Blood…Summary page 3…er Predicate Device K-Number I Clearance Date BD Vacutainer BD VACUTAINERTM K980414 March 3 , 1998 Systems, Brand S afety-LokTM Preanalytical Blood C… | 1998 |
| * | K022875 | Modification to BD Vacutainer Push Button Blood Collection Set | 2002 |
What descends from it? (17)
See all 175 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K153309 | BD Vacutainer UltraTouch Push Button Blood Collection Set | 2016 | 6 |
| K192247 | Steripath Gen2 Blood Collection System | 2020 | 5 |
| K220212 | BD Vacutainer® Push Button Blood Collection Set, BD Vacutainer® Push Button Blood… | 2023 | 1 |
| K112512 | Vanishpoint Blood Collection Set | 2011 | 1 |
| K122355 | Vanishpoint Blood Collection Set | 2013 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 20, 2018 | Class II | Z-1533-2018 | Material/Component Contamination | Products do not meet the labeled sterility claim of a Sterility Assurance Level (SAL) 10-6. |
| Mar 20, 2018 | Class II | Z-1532-2018 | Material/Component Contamination | Products do not meet the labeled sterility claim of a Sterility Assurance Level (SAL) 10-6. |
| Mar 20, 2018 | Class II | Z-1531-2018 | Material/Component Contamination | Products do not meet the labeled sterility claim of a Sterility Assurance Level (SAL) 10-6. |
| Aug 8, 2016 | Class II | Z-0745-2017 | Device Design | BD has received multiple reports of units associated with the 23 G x .75 in. BD Vacutainer Push Button Blood Collection Set with 12 in. Tubing whose lots are exhibiting separation of front and rear barrels upon activation of the safety… |
| Aug 8, 2016 | Class II | Z-2710-2016 | Under Investigation by firm | Becton Dickinson is recalling various lot numbers of BD Vacutainer Push Button Blood Collection Set because of reports that specific lots exhibit separation of fron and rear barrels upon activation of the safety feature, which retracts… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 4 companies; a new generation was cleared every 1.0 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K153309 (Becton, Dickinson and Company, 2016) has gone furthest, with 6 descendants of its own.
- 11 other devices also cite its predicate K980414.
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.
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 VacutainerTM 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 BD VacutainerTM Push Button Blood Collection Set is also iindicated for intravenous administration of fluids as indicated in 21 CFR 5880.5440. It may be used for any patient population with consideration given to patient size and appropriateness for the solution…
Read the full statement (109 words)
The BD VacutainerTM 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 BD VacutainerTM Push Button Blood Collection Set is also iindicated for intravenous administration of fluids as indicated in 21 CFR 5880.5440. It may be used for any patient population with consideration given to patient size and appropriateness for the solution being infused and duration of therapy.
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 accidental needlestick injury.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030573 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030573: BD Vacutainer Push Button Blood Collection Set, Models 367338, 367344, 367336, 367342, 367335, 367341.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030573
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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