510(k) · Cleared
ClearedDual Luer Lock Cap
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Healthcare Corp · FPA Set, Administration, Intravascular
Cleared on Apr 22, 1998 after a 12-day review. The FDA summary names its predicate without a number. 14 later devices descend from it.
- Decided
- Apr 22, 1998
- Review
- 12 days
- Class
- Class II
- Product code
- FPA
- Recalls
- None
- Predicates
- 0
14 later devices descend from it, 3 citing it directly.
- This deviceK981318 Dual Luer Lock CapBaxter Healthcare Corp · 1998
- Descendant · cites it directly · 8 of its ownK093229 Catheter Connections DualcapCatheter Connections, Inc. · 2010
- Descendant · cites it directly · 3 of its ownK101385 Dual Luer Lock Cap, Model 2C6250Baxter Healthcare Corp · 2010
- Descendant · 2 generations on · 2 of its ownK113842 Catheter Connections' Dualcap SoloCatheter Connections, Inc. · 2012
- Descendant · 2 generations on · 1 of its ownK142806 DualCapCatheter Connections, Inc. · 2015
- Descendant · 3 generations on · 1 of its ownK123065 Catheter Connections Dualcap SoloCatheter Connections, Inc. · 2012 · Recalled
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K093229Catheter Connections DualcapCatheter Connections, Inc. · 2010 · cites it directly8descendants
- K101385Dual Luer Lock Cap, Model 2C6250Baxter Healthcare Corp · 2010 · cites it directly3descendants
- K113842Catheter Connections' Dualcap SoloCatheter Connections, Inc. · 2012 · 2 generations on2descendants
- K142806DualCapCatheter Connections, Inc. · 2015 · 2 generations on1descendant
- K123065Catheter Connections Dualcap SoloCatheter Connections, Inc. · 2012 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K981318 | Dual Luer Lock Cap | Baxter Healthcare Corp | 1998 | — |
| +1 | K093229 | Catheter Connections Dualcap | Catheter Connections, Inc. | 2010 | — |
| +1 | K101385 | Dual Luer Lock Cap, Model 2C6250 | Baxter Healthcare Corp | 2010 | — |
| +2 | K113842 | Catheter Connections' Dualcap Solo | Catheter Connections, Inc. | 2012 | — |
| +2 | K142806 | DualCap | Catheter Connections, Inc. | 2015 | — |
| +3 | K123065 | Catheter Connections Dualcap Solo | Catheter Connections, Inc. | 2012 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 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? (3)
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 |
|---|---|---|---|
| * | — | Medex Male/Female Luer Lock Plug Named without a submission number | |
| * | — | B. Braun Blue Cap Dual Function Lock Lock Plug Named without a submission number | |
| * | — | Abbott Male/Female Sterile Cap Named without a submission number |
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K093229 (Catheter Connections, Inc., 2010) has gone furthest, with 8 descendants of its own.
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?
Baxter’s Dual Luer Lock Cap is intended for use as a cap for male or female luer ports on medical devices such as manifolds, stopcocks or sets.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981318 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981318: Dual Luer Lock Cap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981318
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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