510(k) · Cleared
ClearedSaf-T Closed Blood Collection System with Saf-Holder Device, with 21G, 23G, 25G Saf-T Wing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smiths Medical Asd, Inc. · JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Cleared on Jul 21, 2008 as substantially equivalent to K072783 (Smiths Medical Asd, Inc., 2007) and 1 other predicate after an 82-day review. Its family tree reaches back 2 generations to 1989. 13 later devices descend from it.
- Decided
- Jul 21, 2008
- Review
- 82 days
- Class
- Class II
- Product code
- JKA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K895367 (1989). 5 ancestors in all. 13 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK895367 Intravenous Extension SetMedical Product Specialists · 1989 · Recalled
- 1 generation backK072783 Saf-T Closed Blood Collection System with Saf-Holder Device, Model…Smiths Medical Asd, Inc. · 2007
- This deviceK081229 Saf-T Closed Blood Collection System with Saf-Holder Device, with…Smiths Medical Asd, Inc. · 2008
- Descendant · cites it directly · 8 of its ownK142946 TIVAVelano Vascular, Inc. · 2015
- Descendant · 2 generations on · 7 of its ownK152924 TIVA¿Velano Vascular · 2016
- Descendant · 3 generations on · 6 of its ownK163508 PIVOVelano Vascular · 2017
- Descendant · 4 generations on · 5 of its ownK190604 PIVOVelano Vascular · 2019
- Descendant · 5 generations on · 3 of its ownK193569 Pivo (TM)Velano Vascular · 2020 · Recalled
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K142946TIVAVelano Vascular, Inc. · 2015 · cites it directly8descendants
- K152924TIVA¿Velano Vascular · 2016 · 2 generations on7descendants
- K163508PIVOVelano Vascular · 2017 · 3 generations on6descendants
- K190604PIVOVelano Vascular · 2019 · 4 generations on5descendants
- K193569Pivo (TM)Velano Vascular · 2020 · 5 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K895367 | Intravenous Extension Set | Medical Product Specialists | 1989 | 6 |
| −1 | K072783 | Saf-T Closed Blood Collection System with Saf-Holder Device, Model 99200… | Smiths Medical Asd, Inc. | 2007 | — |
| 0 (this device) | K081229 | Saf-T Closed Blood Collection System with Saf-Holder Device, with 21G, 23G… | Smiths Medical Asd, Inc. | 2008 | — |
| +1 | K142946 | TIVA | Velano Vascular, Inc. | 2015 | — |
| +2 | K152924 | TIVA¿ | Velano Vascular | 2016 | — |
| +3 | K163508 | PIVO | Velano Vascular | 2017 | — |
| +4 | K190604 | PIVO | Velano Vascular | 2019 | — |
| +5 | K193569 | Pivo (TM) | Velano Vascular | 2020 | 1 |
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 |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 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 |
|---|---|---|---|
| * | K072783 | Saf-T Closed Blood Collection System with Saf-Holder Device, Model 99200, Saf-T Closed…Summary page 1…Saf-T Closed Blood Collection System® Common Name: Venous Blood Collection Device Classification Name: 862.1675 Blood Specimen Collection Device Predicate Device(s): K072783 (Smiths Medical ASD, Inc.) Saf-T Closed Blood Collection System® Device K922445 (Smiths Medical ASD, Inc.- formerly Concord/Port… | 2007 |
| * | K922445 | Vacu-ProSummary page 1…e Classification Name: 862.1675 Blood Specimen Collection Device Predicate Device(s): K072783 (Smiths Medical ASD, Inc.) Saf-T Closed Blood Collection System® Device K922445 (Smiths Medical ASD, Inc.- formerly Concord/Portex) Venipuncture Needle Pro® Device Device Description: The Saf-… | 1992 |
What descends from it? (13)
See all 132 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 2 companies; a new generation was cleared every 18.1 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K142946 (Velano Vascular, Inc., 2015) has gone furthest, with 8 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. 2008, 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 Saf-T Closed Blood Collection System® device is attached to a peripheral IV catheter at the time of IV catheter placement for use as a direct blood draw device into a vacuum tube or to allow a syringe blood draw and transfer to fill vacuum tubes.
The Saf-T Closed Blood Collection Systenm®device is inteaded for use as a direct blood draw device into a vacuum tube or to allow a syringe blood draw and transfer to fill vacuum tubes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081229 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081229: Saf-T Closed Blood Collection System with Saf-Holder Device, with 21G, 23G, 25G Saf-T Wing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081229
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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