510(k) · Cleared
ClearedDual Luer Lock Cap, Model 2C6250
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 Jun 22, 2010 as substantially equivalent to K981318 (Baxter Healthcare Corp, 1998) after a 35-day review. Its family tree reaches back 1 generation to 1998. 3 later devices descend from it.
- Decided
- Jun 22, 2010
- Review
- 35 days
- Class
- Class II
- Product code
- FPA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K981318 (1998). 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK981318 Dual Luer Lock CapBaxter Healthcare Corp · 1998
- This deviceK101385 Dual Luer Lock Cap, Model 2C6250Baxter Healthcare Corp · 2010
- Descendant · cites it directly · 0 of its ownK200425 Female Luer Lock CapMedsafety Solutions, LLC · 2020
- Descendant · cites it directly · 0 of its ownK182545 Tamper Evident Cap with Male Luer LockInternational Medical Industries, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK140657 Curos Red Port ProtectorIvera Medical, Inc. · 2014
Most influential descendants
Showing 3 of 3 · See all- K200425Female Luer Lock CapMedsafety Solutions, LLC · 2020 · cites it directly0descendants
- K182545Tamper Evident Cap with Male Luer LockInternational Medical Industries, Inc. · 2019 · cites it directly0descendants
- K140657Curos Red Port ProtectorIvera Medical, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K981318 | Dual Luer Lock Cap | Baxter Healthcare Corp | 1998 | — |
| 0 (this device) | K101385 | Dual Luer Lock Cap, Model 2C6250 | Baxter Healthcare Corp | 2010 | — |
| +1 | K200425 | Female Luer Lock Cap | Medsafety Solutions, LLC | 2020 | — |
| +1 | K182545 | Tamper Evident Cap with Male Luer Lock | International Medical Industries, Inc. | 2019 | — |
| +1 | K140657 | Curos Red Port Protector | Ivera Medical, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 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 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? (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 |
|---|---|---|---|
| * | K981318 | Dual Luer Lock CapSummary page 1…date 510(k) _ _ _ _ _ _ _ _ Dual Luer Lock Cap Baxter K981318 April 22, 1998 Healthcare Special 5 10(k) Premarket Notification… | 1998 |
What descends from it? (3)
3 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?
How does its category compare?
All FPA devicesFPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
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 Dual Luer Lock Cap is indicated for use as a cap for male or female Luer ports on medical devices such as manifolds, stopcocks or sets.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101385 · printed Nov 3, 2026
Cite this page
510(k) Report. “K101385: Dual Luer Lock Cap, Model 2C6250.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K101385
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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