510(k) · Cleared
ClearedPIVO™ Pro Needle-free Blood Collection Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton Dickinson Infusion Therapy Systems, Inc. · JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Cleared on Sep 28, 2023 as substantially equivalent to K193569 (Velano Vascular, 2020) after a 183-day review. Its family tree reaches back 8 generations to 1989. 2 later devices descend from it.
- Decided
- Sep 28, 2023
- Review
- 183 days
- Class
- Class II
- Product code
- JKA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K895367 (1989). 11 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK895367 Intravenous Extension SetMedical Product Specialists · 1989 · Recalled
- 7 generations backK072783 Saf-T Closed Blood Collection System with Saf-Holder Device, Model…Smiths Medical Asd, Inc. · 2007
- 6 generations backK081229 Saf-T Closed Blood Collection System with Saf-Holder Device, with…Smiths Medical Asd, Inc. · 2008
- 5 generations backK142946 TIVAVelano Vascular, Inc. · 2015
- 4 generations backK152924 TIVA¿Velano Vascular · 2016
- 3 generations backK163508 PIVOVelano Vascular · 2017
- 2 generations backK190604 PIVOVelano Vascular · 2019
- 1 generation backK193569 Pivo (TM)Velano Vascular · 2020 · Recalled
- This deviceK230865 PIVO™ Pro Needle-free Blood Collection DeviceBecton Dickinson Infusion Therapy Systems, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK244047 Navi™ Needle-free Blood Collection Device (VNC20500FG, VNC22500FG…Venocare, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK241586 PIVO™ Pro Needle-free Blood Collection DeviceBecton Dickinson Infusion Therapy Systems, Inc. · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K895367 | Intravenous Extension Set | Medical Product Specialists | 1989 | 6 |
| −7 | K072783 | Saf-T Closed Blood Collection System with Saf-Holder Device, Model 99200… | Smiths Medical Asd, Inc. | 2007 | — |
| −6 | K081229 | Saf-T Closed Blood Collection System with Saf-Holder Device, with 21G, 23G… | Smiths Medical Asd, Inc. | 2008 | — |
| −5 | K142946 | TIVA | Velano Vascular, Inc. | 2015 | — |
| −4 | K152924 | TIVA¿ | Velano Vascular | 2016 | — |
| −3 | K163508 | PIVO | Velano Vascular | 2017 | — |
| −2 | K190604 | PIVO | Velano Vascular | 2019 | — |
| −1 | K193569 | Pivo (TM) | Velano Vascular | 2020 | 1 |
| 0 (this device) | K230865 | PIVO™ Pro Needle-free Blood Collection Device | Becton Dickinson Infusion Therapy Systems, Inc. | 2023 | — |
| +1 | K244047 | Navi™ Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG) | Venocare, Inc. | 2025 | — |
| +1 | K241586 | PIVO™ Pro Needle-free Blood Collection Device | Becton Dickinson Infusion Therapy Systems, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1992 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K193569 | Pivo (TM)Summary page 5…me: PIVO™ Needle-free Blood Collection Device Device Common Name: Blood Collection Device 510(k) Reference: K193569 Regulation Number: 21 CFR 862.1675 Regulation Name: Blood Specimen Collection D… | 2020 |
What descends from it? (2)
2 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 34 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
- 2 of the 11 ancestors have a recall of any class.
- Of its descendants, K244047 (Venocare, Inc., 2025) has gone furthest, with 0 descendants of its own.
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. 2023, 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 PIVO™ Pro Needle-free Blood Collection Device attaches to a peripheral IV catheter system for use to obtain venous blood specimens into a vacuum tube or syringe from adult and pediatric patients, including those with difficult intravenous access who may have small, fragile, and/or non-palpable veins.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230865 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230865: PIVO™ Pro Needle-free Blood Collection Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230865
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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