510(k) · Cleared
Recalled · Class II · 2025Texium Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardinal Health, Alaris Products · FMF Syringe, Piston
Cleared on May 24, 2007 as substantially equivalent to K053049 (Cardinal Health, Alaris Products, 2006) and 1 other predicate after a 35-day review. Its family tree reaches back 3 generations to 1988. 11 later devices descend from it. It has been recalled once.
- Decided
- May 24, 2007
- Review
- 35 days
- Class
- Class II
- Product code
- FMF
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 3 generations to K883614 (1988). 8 ancestors in all. 11 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK883614 Cytoguard (R)Survival Technology, Inc. · 1988
- 2 generations backK972527 Phaseal, System for Sealed Handling of Chemotherapeutic AgentsQuality System Consulting · 1997
- 1 generation backK053049 Alaris Safety Male LuerCardinal Health, Alaris Products · 2006 · Recalled
- This deviceK071108 Texium SyringeCardinal Health, Alaris Products · 2007
- Descendant · cites it directly · 9 of its ownK083152 Equashield SystemPlastmed, Ltd. · 2009
- Descendant · 2 generations on · 8 of its ownK091389 Equalshield Luer Lock Connector PairPlastmed, Ltd. · 2009
- Descendant · 2 generations on · 7 of its ownK101940 Equashield System Protective PlusEquashield Medical, Ltd. · 2010
- Descendant · 3 generations on · 6 of its ownK132899 Equashield Closed System Drug Transfer Device (CSTD)Equashield Medical, Ltd. · 2014
- Descendant · 4 generations on · 5 of its ownK170706 Equashield Closed System drug Transfer Device (CSTD)Equashield Medical, Ltd. · 2017
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K083152Equashield SystemPlastmed, Ltd. · 2009 · cites it directly9descendants
- K091389Equalshield Luer Lock Connector PairPlastmed, Ltd. · 2009 · 2 generations on8descendants
- K101940Equashield System Protective PlusEquashield Medical, Ltd. · 2010 · 2 generations on7descendants
- K132899Equashield Closed System Drug Transfer Device (CSTD)Equashield Medical, Ltd. · 2014 · 3 generations on6descendants
- K170706Equashield Closed System drug Transfer Device (CSTD)Equashield Medical, Ltd. · 2017 · 4 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K883614 | Cytoguard (R) | Survival Technology, Inc. | 1988 | — |
| −2 | K972527 | Phaseal, System for Sealed Handling of Chemotherapeutic Agents | Quality System Consulting | 1997 | — |
| −1 | K053049 | Alaris Safety Male Luer | Cardinal Health, Alaris Products | 2006 | 3 |
| 0 (this device) | K071108 | Texium Syringe | Cardinal Health, Alaris Products | 2007 | — |
| +1 | K083152 | Equashield System | Plastmed, Ltd. | 2009 | — |
| +2 | K091389 | Equalshield Luer Lock Connector Pair | Plastmed, Ltd. | 2009 | — |
| +2 | K101940 | Equashield System Protective Plus | Equashield Medical, Ltd. | 2010 | — |
| +3 | K132899 | Equashield Closed System Drug Transfer Device (CSTD) | Equashield Medical, Ltd. | 2014 | — |
| +4 | K170706 | Equashield Closed System drug Transfer Device (CSTD) | Equashield Medical, Ltd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1997 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 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 FMF? 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 FMF device
- #1 K241821 Luer Lock Syringe with Safety Needle; Luer…score 16.2 · 8 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 |
|---|---|---|---|
| * | K053049 | Alaris Safety Male LuerSummary page 1…inge is a single use piston syringe that consists of a syringe (3mL, 5mL, 1OmL, 2OmL or 6OmL) permanently bonded to a closed male luer device (TexiumTm Closed Male Luer, K053049). The TeXiumTM Syringe is designed to promote safe handling of fluids and medications, particularly hazardous or cytotoxic drugs.… | 2006 |
| * | K954064 | Becton Dickinson SyringseSummary page 2…049 1/12/06 (originally submitted as the Products Alaris® Safety Male Luer Becton Dickinson Syringe Becton Dickinson & Company K954064 11/21/95 INTENDED USE The TexiumTM Syringe is intended to provide leak-free handling of potentially hazardous fluids,… | 1995 |
What descends from it? (11)
See all 112 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 12, 2025 | Class II | Z-1971-2025 | Process control | Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes, may leak at the interface between the closed male luer component and the needle-free connector, which may cause procedure delay… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 8.3 years on median.
- 3 of the 8 ancestors have a recall of any class.
- Of its descendants, K083152 (Plastmed, Ltd., 2009) has gone furthest, with 9 descendants of its own.
- 2 other devices also cite its predicate K053049.
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · FMF
13in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMF
114in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FMF
19in 2023
Class I (19 since 2007) Class II/III not classified
Adverse event reports per year · FMF
4,181in 2025
MAUDE reports naming product code FMF, 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 | 23 | 90 | 6 | 674 |
| 2008 | 9 | 74 | 11 | 691 |
| 2009 | 14 | 94 | 15 | 913 |
| 2010 | 11 | 130 | 12 | 679 |
| 2011 | 16 | 109 | 3 | 186 |
| 2012 | 9 | 86 | 6 | 307 |
| 2013 | 12 | 154 | 1 | 326 |
| 2014 | 13 | 84 | 1 | 244 |
| 2015 | 11 | 87 | 2 | 273 |
| 2016 | 12 | 146 | 0 | 684 |
| 2017 | 13 | 135 | 3 | 1,858 |
| 2018 | 8 | 87 | 2 | 3,952 |
| 2019 | 11 | 146 | 1 | 5,863 |
| 2020 | 15 | 107 | 2 | 5,334 |
| 2021 | 20 | 175 | 1 | 5,874 |
| 2022 | 24 | 211 | 2 | 5,233 |
| 2023 | 22 | 173 | 19 (18) | 5,214 |
| 2024 | 14 | 130 | 0 | 5,122 |
| 2025 | 13 | 114 | 0 | 4,181 |
| 2026 | 9 | 239 | 2 (1) | — |
What is it indicated for?
The TexiumTM Syringe is indicated for use by healthcare professionals for fluid aspiration/injection, reconstituting, dispensing/ transferring, administering, and disposal of potentially hazardous fluids, such as chemotherapy, radioactive isotopes, and blood products, as well as non-hazardous fluids. The TexiumTM Syringe is intended for use with the SmartSite® Needle Free Valve port or standard open female luers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071108 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071108: Texium Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071108
Report an extraction error
Are you the manufacturer?
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