510(k) · Cleared
Recalled · Class II · 2025Alaris Safety Male Luer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardinal Health, Alaris Products · FPA Set, Administration, Intravascular
Cleared on Jan 12, 2006 as substantially equivalent to K972527 (Quality System Consulting, 1997) and 1 other predicate after a 76-day review. Its family tree reaches back 2 generations to 1988. 14 later devices descend from it. It has been recalled 3 times.
- Decided
- Jan 12, 2006
- Review
- 76 days
- Class
- Class II
- Product code
- FPA
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 2 generations to K883614 (1988). 6 ancestors in all. 14 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK883614 Cytoguard (R)Survival Technology, Inc. · 1988
- 1 generation backK972527 Phaseal, System for Sealed Handling of Chemotherapeutic AgentsQuality System Consulting · 1997
- This deviceK053049 Alaris Safety Male LuerCardinal Health, Alaris Products · 2006
- Descendant · cites it directly · 11 of its ownK071108 Texium SyringeCardinal Health, Alaris Products · 2007 · Recalled
- Descendant · 2 generations on · 9 of its ownK083152 Equashield SystemPlastmed, Ltd. · 2009
- Descendant · 3 generations on · 8 of its ownK091389 Equalshield Luer Lock Connector PairPlastmed, Ltd. · 2009
- Descendant · 3 generations on · 7 of its ownK101940 Equashield System Protective PlusEquashield Medical, Ltd. · 2010
- Descendant · 4 generations on · 6 of its ownK132899 Equashield Closed System Drug Transfer Device (CSTD)Equashield Medical, Ltd. · 2014
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K071108Texium SyringeCardinal Health, Alaris Products · 2007 · cites it directly11descendants
- K083152Equashield SystemPlastmed, Ltd. · 2009 · 2 generations on9descendants
- K091389Equalshield Luer Lock Connector PairPlastmed, Ltd. · 2009 · 3 generations on8descendants
- K101940Equashield System Protective PlusEquashield Medical, Ltd. · 2010 · 3 generations on7descendants
- K132899Equashield Closed System Drug Transfer Device (CSTD)Equashield Medical, Ltd. · 2014 · 4 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K883614 | Cytoguard (R) | Survival Technology, Inc. | 1988 | — |
| −1 | K972527 | Phaseal, System for Sealed Handling of Chemotherapeutic Agents | Quality System Consulting | 1997 | — |
| 0 (this device) | K053049 | Alaris Safety Male Luer | Cardinal Health, Alaris Products | 2006 | — |
| +1 | K071108 | Texium Syringe | Cardinal Health, Alaris Products | 2007 | 1 |
| +2 | K083152 | Equashield System | Plastmed, Ltd. | 2009 | — |
| +3 | K091389 | Equalshield Luer Lock Connector Pair | Plastmed, Ltd. | 2009 | — |
| +3 | K101940 | Equashield System Protective Plus | Equashield Medical, Ltd. | 2010 | — |
| +4 | K132899 | Equashield Closed System Drug Transfer Device (CSTD) | Equashield Medical, Ltd. | 2014 | — |
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 |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 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 FPA? 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 FPA device
- #1 K243841 Sparta Infusion Set for Insulinscore 13.4 · 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 |
|---|---|---|---|
| * | K972527 | Phaseal, System for Sealed Handling of Chemotherapeutic AgentsSummary page 2…type and is substantially equivalent to the following predicate devices: PhaSeal System arma AB K972527 9/18/97 CML 1000 ICU Medical, Inc. K051437 8 INTENDED USE The Safety… | 1997 |
| * | K051437 | CML 1000Summary page 2…icate devices: PhaSeal System arma AB K972527 9/18/97 CML 1000 ICU Medical, Inc. K051437 8 INTENDED USE The Safety Male Luer is intended to provide leak-free handling of… | 2005 |
What descends from it? (14)
See all 143 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-1970-2025 | 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… |
| May 12, 2025 | Class II | Z-1973-2025 | 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… |
| Aug 30, 2007 | Not classified | Z-0218-2008 | Finished device change control | Leaks: there is a risk of leakage at the female end of the Texium closed male luer (CML) when attached to a spin luer. (NOTE: users who connect the female portion of the Texium closed male luer to fixed (one-piece) male luers on tubing or… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 9.0 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K071108 (Cardinal Health, Alaris Products, 2007) has gone furthest, with 11 descendants of its own.
- 4 other devices also cite its predicate K972527.
How does its category compare?
All FPA devicesFPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FPA
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FPA
225in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FPA
98in 2025
Class I (17 since 2007) Class II/III not classified
Adverse event reports per year · FPA
34,506in 2025
MAUDE reports naming product code FPA, 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 | 16 | 75 | 17 | 1,499 |
| 2008 | 18 | 89 | 15 | 1,941 |
| 2009 | 10 | 166 | 166 | 2,512 |
| 2010 | 23 | 120 | 58 | 2,537 |
| 2011 | 12 | 87 | 28 | 4,407 |
| 2012 | 21 | 96 | 16 (4) | 4,930 |
| 2013 | 13 | 90 | 64 | 4,651 |
| 2014 | 22 | 89 | 24 | 4,695 |
| 2015 | 17 | 123 | 6 | 6,625 |
| 2016 | 12 | 195 | 10 | 8,470 |
| 2017 | 17 | 240 | 13 | 6,462 |
| 2018 | 4 | 177 | 4 | 6,574 |
| 2019 | 7 | 161 | 13 | 11,227 |
| 2020 | 10 | 327 | 107 | 9,563 |
| 2021 | 13 | 186 | 1 | 10,414 |
| 2022 | 14 | 213 | 9 (5) | 13,393 |
| 2023 | 14 | 340 | 12 (4) | 10,916 |
| 2024 | 7 | 244 | 13 (1) | 47,210 |
| 2025 | 11 | 225 | 98 (1) | 34,506 |
| 2026 | 5 | 266 | 10 (2) | — |
What is it indicated for?
The Safety Male Luer is indicated for use when 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 Safety Male Luer 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/K053049 · printed Nov 5, 2026
Cite this page
510(k) Report. “K053049: Alaris Safety Male Luer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053049
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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