510(k) · Cleared
ClearedSaf-T Holder Multi Sample Luer Adapter W/ Blood
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ryan Medical, Inc. · JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Cleared on Sep 1, 1992 after a 68-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 18 later devices descend from it.
- Decided
- Sep 1, 1992
- Review
- 68 days
- Class
- Class II
- Product code
- JKA
- Recalls
- None
- Predicates
- 0
18 later devices descend from it, 2 citing it directly.
- This deviceK923090 Saf-T Holder Multi Sample Luer Adapter W/ BloodRyan Medical, Inc. · 1992
- Descendant · cites it directly · 14 of its ownK072783 Saf-T Closed Blood Collection System with Saf-Holder Device, Model…Smiths Medical Asd, Inc. · 2007
- Descendant · 2 generations on · 13 of its ownK081229 Saf-T Closed Blood Collection System with Saf-Holder Device, with…Smiths Medical Asd, Inc. · 2008
- Descendant · 3 generations on · 8 of its ownK142946 TIVAVelano Vascular, Inc. · 2015
- Descendant · 4 generations on · 7 of its ownK152924 TIVA¿Velano Vascular · 2016
- Descendant · 5 generations on · 6 of its ownK163508 PIVOVelano Vascular · 2017
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K072783Saf-T Closed Blood Collection System with Saf-Holder Device, Model 99200, Saf-T Closed…Smiths Medical Asd, Inc. · 2007 · cites it directly14descendants
- K081229Saf-T Closed Blood Collection System with Saf-Holder Device, with 21G, 23G, 25G Saf-T WingSmiths Medical Asd, Inc. · 2008 · 2 generations on13descendants
- K142946TIVAVelano Vascular, Inc. · 2015 · 3 generations on8descendants
- K152924TIVA¿Velano Vascular · 2016 · 4 generations on7descendants
- K163508PIVOVelano Vascular · 2017 · 5 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K923090 | Saf-T Holder Multi Sample Luer Adapter W/ Blood | Ryan Medical, Inc. | 1992 | — |
| +1 | K072783 | Saf-T Closed Blood Collection System with Saf-Holder Device, Model 99200… | Smiths Medical Asd, Inc. | 2007 | — |
| +2 | 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 | — |
| +4 | K152924 | TIVA¿ | Velano Vascular | 2016 | — |
| +5 | K163508 | PIVO | Velano Vascular | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (18)
See all 182 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?
- Of its descendants, K072783 (Smiths Medical Asd, Inc., 2007) has gone furthest, with 14 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.
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 | — |
https://510kreport.com/device/K923090 · printed Nov 5, 2026
Cite this page
510(k) Report. “K923090: Saf-T Holder Multi Sample Luer Adapter W/ Blood.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K923090
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026