510(k) · Cleared
ClearedPIVO
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Velano Vascular · JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Cleared on May 13, 2019 as substantially equivalent to K163508 (Velano Vascular, 2017) after a 66-day review. Its family tree reaches back 6 generations to 1989. 5 later devices descend from it.
- Decided
- May 13, 2019
- Review
- 66 days
- Class
- Class II
- Product code
- JKA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K895367 (1989). 9 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK895367 Intravenous Extension SetMedical Product Specialists · 1989 · Recalled
- 5 generations backK072783 Saf-T Closed Blood Collection System with Saf-Holder Device, Model…Smiths Medical Asd, Inc. · 2007
- 4 generations backK081229 Saf-T Closed Blood Collection System with Saf-Holder Device, with…Smiths Medical Asd, Inc. · 2008
- 3 generations backK142946 TIVAVelano Vascular, Inc. · 2015
- 2 generations backK152924 TIVA¿Velano Vascular · 2016
- 1 generation backK163508 PIVOVelano Vascular · 2017
- This deviceK190604 PIVOVelano Vascular · 2019
- Descendant · cites it directly · 3 of its ownK193569 Pivo (TM)Velano Vascular · 2020 · Recalled
- Descendant · 2 generations on · 2 of its ownK230865 PIVO™ Pro Needle-free Blood Collection DeviceBecton Dickinson Infusion Therapy Systems, Inc. · 2023
- Descendant · 3 generations on · 0 of its ownK244047 Navi™ Needle-free Blood Collection Device (VNC20500FG, VNC22500FG…Venocare, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK241586 PIVO™ Pro Needle-free Blood Collection DeviceBecton Dickinson Infusion Therapy Systems, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK220258 20G Open-System Ally Device Kit (AV100000), 22G Open-System Ally…Avia Vascular · 2022
Most influential descendants
Showing 5 of 5 · See all- K193569Pivo (TM)Velano Vascular · 2020 · cites it directly3descendants
- K230865PIVO™ Pro Needle-free Blood Collection DeviceBecton Dickinson Infusion Therapy Systems, Inc. · 2023 · 2 generations on2descendants
- K244047Navi™ Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG)Venocare, Inc. · 2025 · 3 generations on0descendants
- K241586PIVO™ Pro Needle-free Blood Collection DeviceBecton Dickinson Infusion Therapy Systems, Inc. · 2025 · 3 generations on0descendants
- K22025820G Open-System Ally Device Kit (AV100000), 22G Open-System Ally Device Kit (AV110000)Avia Vascular · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K895367 | Intravenous Extension Set | Medical Product Specialists | 1989 | 6 |
| −5 | K072783 | Saf-T Closed Blood Collection System with Saf-Holder Device, Model 99200… | Smiths Medical Asd, Inc. | 2007 | — |
| −4 | K081229 | Saf-T Closed Blood Collection System with Saf-Holder Device, with 21G, 23G… | Smiths Medical Asd, Inc. | 2008 | — |
| −3 | K142946 | TIVA | Velano Vascular, Inc. | 2015 | — |
| −2 | K152924 | TIVA¿ | Velano Vascular | 2016 | — |
| −1 | K163508 | PIVO | Velano Vascular | 2017 | — |
| 0 (this device) | K190604 | PIVO | Velano Vascular | 2019 | — |
| +1 | K193569 | Pivo (TM) | Velano Vascular | 2020 | 1 |
| +2 | K230865 | PIVO™ Pro Needle-free Blood Collection Device | Becton Dickinson Infusion Therapy Systems, Inc. | 2023 | — |
| +3 | K244047 | Navi™ Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG) | Venocare, Inc. | 2025 | — |
| +3 | K241586 | PIVO™ Pro Needle-free Blood Collection Device | Becton Dickinson Infusion Therapy Systems, Inc. | 2025 | — |
| +1 | K220258 | 20G Open-System Ally Device Kit (AV100000), 22G Open-System Ally Device Kit… | Avia Vascular | 2022 | — |
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 |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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? (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 |
|---|---|---|---|
| * | K163508 | PIVOSummary page 4…Product Code: JKA per 21CFR 862.1675 Predicate Device(s): The subject device is equivalent to the following devices: • K163508 – PIVO™ Device Description: The PIVO™ device is a sterile, single use device. It is a needle- fre… | 2017 |
What descends from it? (5)
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 30 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K193569 (Velano Vascular, 2020) has gone furthest, with 3 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. 2019, 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™ device attaches to a peripheral IV catheter system for use as a direct blood draw device into a vacuum tube or a syringe.
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/K190604 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190604: PIVO.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190604
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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