510(k) · Cleared
Recalled · Class II · 2021Pivo (TM)
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 Jan 21, 2020 as substantially equivalent to K190604 (Velano Vascular, 2019) after a 29-day review. Its family tree reaches back 7 generations to 1989. 3 later devices descend from it. It has been recalled once.
- Decided
- Jan 21, 2020
- Review
- 29 days
- Class
- Class II
- Product code
- JKA
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 7 generations to K895367 (1989). 10 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK895367 Intravenous Extension SetMedical Product Specialists · 1989 · Recalled
- 6 generations backK072783 Saf-T Closed Blood Collection System with Saf-Holder Device, Model…Smiths Medical Asd, Inc. · 2007
- 5 generations backK081229 Saf-T Closed Blood Collection System with Saf-Holder Device, with…Smiths Medical Asd, Inc. · 2008
- 4 generations backK142946 TIVAVelano Vascular, Inc. · 2015
- 3 generations backK152924 TIVA¿Velano Vascular · 2016
- 2 generations backK163508 PIVOVelano Vascular · 2017
- 1 generation backK190604 PIVOVelano Vascular · 2019
- This deviceK193569 Pivo (TM)Velano Vascular · 2020
- Descendant · cites it directly · 2 of its ownK230865 PIVO™ Pro Needle-free Blood Collection DeviceBecton Dickinson Infusion Therapy Systems, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK244047 Navi™ Needle-free Blood Collection Device (VNC20500FG, VNC22500FG…Venocare, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK241586 PIVO™ Pro Needle-free Blood Collection DeviceBecton Dickinson Infusion Therapy Systems, Inc. · 2025
Most influential descendants
Showing 3 of 3 · See all- K230865PIVO™ Pro Needle-free Blood Collection DeviceBecton Dickinson Infusion Therapy Systems, Inc. · 2023 · cites it directly2descendants
- K244047Navi™ Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG)Venocare, Inc. · 2025 · 2 generations on0descendants
- K241586PIVO™ Pro Needle-free Blood Collection DeviceBecton Dickinson Infusion Therapy Systems, Inc. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K895367 | Intravenous Extension Set | Medical Product Specialists | 1989 | 6 |
| −6 | K072783 | Saf-T Closed Blood Collection System with Saf-Holder Device, Model 99200… | Smiths Medical Asd, Inc. | 2007 | — |
| −5 | K081229 | Saf-T Closed Blood Collection System with Saf-Holder Device, with 21G, 23G… | Smiths Medical Asd, Inc. | 2008 | — |
| −4 | K142946 | TIVA | Velano Vascular, Inc. | 2015 | — |
| −3 | K152924 | TIVA¿ | Velano Vascular | 2016 | — |
| −2 | K163508 | PIVO | Velano Vascular | 2017 | — |
| −1 | K190604 | PIVO | Velano Vascular | 2019 | — |
| 0 (this device) | K193569 | Pivo (TM) | Velano Vascular | 2020 | — |
| +1 | K230865 | PIVO™ Pro Needle-free Blood Collection Device | Becton Dickinson Infusion Therapy Systems, Inc. | 2023 | — |
| +2 | K244047 | Navi™ Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG) | Venocare, Inc. | 2025 | — |
| +2 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K190604 | PIVOSummary page 4…JKA per 21CFR 862.1675 Predicate Device(s): The subject device is equivalent to the following devices: • K190604 – PIVO™ Device Description: The PIVO™ device is a sterile, single use device. It is a needle-… | 2019 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230865 | PIVO™ Pro Needle-free Blood Collection Device | 2023 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 10, 2021 | Class II | Z-0527-2022 | Process control | Incomplete sealing of blood collection device unit packages may produce a breach in the sterile barrier enclosing the product. This could lead to microbial contamination of the device prior to use. The health effects range from no… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 31 years and passes through 4 companies; a new generation was cleared every 1.1 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K230865 (Becton Dickinson Infusion Therapy Systems, Inc., 2023) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K190604.
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. 2020, 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 is attached to a peripheral IV catheter for use as a direct blood draw device into a vacuum tube or a syringe.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193569 · printed Nov 4, 2026
Cite this page
510(k) Report. “K193569: Pivo (TM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K193569
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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