510(k) · Cleared
ClearedBD Texium™ Needle-Free Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Care Fusion · FMF Syringe, Piston
Cleared on Sep 25, 2023 as substantially equivalent to K071108 (Cardinal Health, Alaris Products, 2007) and 1 other predicate after a 90-day review. Its family tree reaches back 4 generations to 1988.
- Decided
- Sep 25, 2023
- Review
- 90 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K883614 (1988). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK883614 Cytoguard (R)Survival Technology, Inc. · 1988
- 3 generations backK972527 Phaseal, System for Sealed Handling of Chemotherapeutic AgentsQuality System Consulting · 1997
- 2 generations backK053049 Alaris Safety Male LuerCardinal Health, Alaris Products · 2006 · Recalled
- 1 generation backK071108 Texium SyringeCardinal Health, Alaris Products · 2007 · Recalled
- This deviceK231888 BD Texium™ Needle-Free SyringeCare Fusion · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K883614 | Cytoguard (R) | Survival Technology, Inc. | 1988 | — |
| −3 | K972527 | Phaseal, System for Sealed Handling of Chemotherapeutic Agents | Quality System Consulting | 1997 | — |
| −2 | K053049 | Alaris Safety Male Luer | Cardinal Health, Alaris Products | 2006 | 3 |
| −1 | K071108 | Texium Syringe | Cardinal Health, Alaris Products | 2007 | 1 |
| 0 (this device) | K231888 | BD Texium™ Needle-Free Syringe | Care Fusion | 2023 | — |
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 |
| 2023 | 1 | 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 16.1 · 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 |
|---|---|---|---|
| * | K071108 | Texium SyringeSummary page 4…ton Syringe Regulatory Class: Class II Product Code: FMF Classification Panel: General Hospital Premarket Notification: K071108 Secondary Predicate Device Identification Trade/Proprietary Name: BD TexiumTM Closed Male Luer Common Name:… | 2007 |
| * | K223076 | BD Texium™ Closed Male LuerSummary page 5…exium™ Needle-Free Syringe Product Code: ONB Classification Panel: General Hospital Premarket Notification: K223076 Reason for the Submission The reason for this submission is to incorporate the following changes: • Including the recently c… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
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 35 years and passes through 4 companies; a new generation was cleared every 9.0 years on median.
- 4 of the 10 ancestors have a recall of any class.
- 1 other device also cites its predicate K071108.
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 BD Texium™ Needle-Free Syringe is a sterile, single-use closed system drug transfer device (CSTD) incorporating a bonded Texium™ Closed Male Luer and Syringe, intended for preparation and administration of hazardous and non-hazardous drugs when paired with the SmartSite™ Needle-free Connector (NFC). When paired with devices containing a SmartSite™ NFC the BD Texium™ Needle-Free Syringe mechanically prohibits the transfer of environmental contaminants…
Read the full statement (96 words)
The BD Texium™ Needle-Free Syringe is a sterile, single-use closed system drug transfer device (CSTD) incorporating a bonded Texium™ Closed Male Luer and Syringe, intended for preparation and administration of hazardous and non-hazardous drugs when paired with the SmartSite™ Needle-free Connector (NFC). When paired with devices containing a SmartSite™ NFC the BD Texium™ Needle-Free Syringe mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug vapor concentrations outside the BD Texium™ Needle-Free Syringe/SmartSite™ NFC connection, thereby minimizing individual and environmental exposure to drugs, leaks, and spills. (e.g., airtight, leak-free and drip-free).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231888 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231888: BD Texium™ Needle-Free Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231888
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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