510(k) · Cleared
ClearedBD Texium™ Closed Male Luer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Care Fusion · ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
Cleared on Mar 24, 2023 as substantially equivalent to K053049 (Cardinal Health, Alaris Products, 2006) after a 175-day review. Its family tree reaches back 3 generations to 1988. 1 later device descends from it.
- Decided
- Mar 24, 2023
- Review
- 175 days
- Class
- Class II
- Product code
- ONB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K883614 (1988). 7 ancestors in all. 1 later device descends from it, 1 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 deviceK223076 BD Texium™ Closed Male LuerCare Fusion · 2023
- Descendant · cites it directly · 0 of its ownK231888 BD Texium™ Needle-Free SyringeCare Fusion · 2023
Most influential descendants
Showing 1 of 1 · See all- K231888BD Texium™ Needle-Free SyringeCare Fusion · 2023 · cites it directly0descendants
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) | K223076 | BD Texium™ Closed Male Luer | Care Fusion | 2023 | — |
| +1 | 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 | 1 | 0 |
| 1997 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 ONB? 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 ONB device
- #1 K240171 ProSeal™ Injector Plus (Model no. 421050)score 18.2 · 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? (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 |
|---|---|---|---|
| * | K053049 | Alaris Safety Male LuerSummary page 4…Class II Product Code: FPA Classification Panel: General Hospital Premarket Notification: K053049 Reason for the Submission The reason for this submission is to incorporate the following changes: • New sterilization cl… | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231888 | BD Texium™ Needle-Free Syringe | 2023 | 0 |
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.
- 3 of the 7 ancestors have a recall of any class.
- Of its descendants, K231888 (Care Fusion, 2023) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K053049.
How does its category compare?
All ONB devicesONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · ONB
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ONB
60in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ONB
38in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · ONB
934in 2025
MAUDE reports naming product code ONB, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 3 | 58 | 0 | 2 |
| 2014 | 2 | — | 0 | 3 |
| 2015 | 3 | 235 | 0 | 4 |
| 2016 | 0 | — | 1 | 13 |
| 2017 | 2 | — | 0 | 66 |
| 2018 | 6 | 249 | 0 | 228 |
| 2019 | 1 | — | 1 (1) | 464 |
| 2020 | 3 | 213 | 4 | 442 |
| 2021 | 3 | 277 | 0 | 548 |
| 2022 | 1 | — | 1 | 448 |
| 2023 | 3 | 175 | 1 | 456 |
| 2024 | 8 | 102 | 1 | 686 |
| 2025 | 6 | 60 | 38 | 934 |
| 2026 | 0 | — | 3 | — |
What is it indicated for?
The BD Texium™ Closed Male Luer (CML) is a sterile, single-use closed system drug transfer device (CSTD) intended for the reconstitution, transfer and administration of hazardous and non-hazardous drugs when paired with the SmartSite™ NFC.
The BD Texium™ Closed Male Luer (CML) is indicated for use by trained healthcare professionals within healthcare facilities who prepare and/or administer non-hazardous and hazardous drugs for adults, pediatrics and neonates.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223076 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223076: BD Texium™ Closed Male Luer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223076
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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