510(k) · Cleared
Recalled · Class II · 2025Caresite Luer Access Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
B.Braun Medical, Inc. · FPA Set, Administration, Intravascular
Cleared on May 7, 2014 as substantially equivalent to K083723 (B.Braun Medical, Inc., 2009) after an 89-day review. Its family tree reaches back 4 generations to 1995. 1 later device descends from it. It has been recalled 21 times.
- Decided
- May 7, 2014
- Review
- 89 days
- Class
- Class II
- Product code
- FPA
- Recalls
- 21
- Predicates
- 1
Its longest line of descent runs back 4 generations to K942988 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK942988 Filtered Extension SetsB. Braun of America, Inc. · 1995 · Recalled
- 3 generations backK955585 V2 Injection SiteB.Braun Medical, Inc. · 1996 · Recalled
- 2 generations backK031923 Ultrasite ValveB.Braun Medical, Inc. · 2003
- 1 generation backK083723 A6 Luer Access DeviceB.Braun Medical, Inc. · 2009 · Recalled
- This deviceK140311 Caresite Luer Access DeviceB.Braun Medical, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK212842 Microvolume Luer Access DeviceB.Braun Medical, Inc. · 2022
Most influential descendants
Showing 1 of 1 · See all- K212842Microvolume Luer Access DeviceB.Braun Medical, Inc. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K942988 | Filtered Extension Sets | B. Braun of America, Inc. | 1995 | 32 |
| −3 | K955585 | V2 Injection Site | B.Braun Medical, Inc. | 1996 | 27 |
| −2 | K031923 | Ultrasite Valve | B.Braun Medical, Inc. | 2003 | — |
| −1 | K083723 | A6 Luer Access Device | B.Braun Medical, Inc. | 2009 | 66 |
| 0 (this device) | K140311 | Caresite Luer Access Device | B.Braun Medical, Inc. | 2014 | — |
| +1 | K212842 | Microvolume Luer Access Device | B.Braun Medical, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 |
|---|---|---|---|
| * | K083723 | A6 Luer Access DeviceSummary page 1…Intravascular Administration Set Classification Product Code: FPA PREDICATE DEVICE: 5 10(k) Number: K083723 Device Name: A6 Luer Access Device Classification Product Cod… | 2009 |
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 |
|---|---|---|---|
| K212842 | Microvolume Luer Access Device | 2022 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 29, 2025 | Class II | Z-0621-2026 | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). |
| Oct 29, 2025 | Class II | Z-0618-2026 | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). |
| Oct 29, 2025 | Class II | Z-0620-2026 | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). |
| Oct 29, 2025 | Class II | Z-0665-2026 | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). |
| Oct 29, 2025 | Class II | Z-0666-2026 | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). |
| Oct 29, 2025 | Class II | Z-0667-2026 | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). |
| Oct 29, 2025 | Class II | Z-0671-2026 | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). |
| Oct 29, 2025 | Class II | Z-0672-2026 | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). |
| Oct 29, 2025 | Class II | Z-0668-2026 | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). |
| Oct 29, 2025 | Class II | Z-0682-2026 | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). |
| Oct 29, 2025 | Class II | Z-0697-2026 | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). |
| Oct 29, 2025 | Class II | Z-0674-2026 | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). |
| Oct 29, 2025 | Class II | Z-0686-2026 | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). |
| Jun 17, 2024 | Class II | Z-2404-2024 | Process control | Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction… |
| Aug 10, 2021 | Class II | Z-2553-2021 | Under Investigation by firm | Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections. |
| Aug 10, 2021 | Class II | Z-2555-2021 | Under Investigation by firm | Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections. |
| Aug 10, 2021 | Class II | Z-2557-2021 | Under Investigation by firm | Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections. |
| Aug 10, 2021 | Class II | Z-2554-2021 | Under Investigation by firm | Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections. |
| Nov 20, 2019 | Class II | Z-0935-2020 | Nonconforming Material/Component | Potential for leakage at the joint between the blood filters and tubing |
| Nov 20, 2019 | Class II | Z-0939-2020 | Nonconforming Material/Component | Potential for leakage at the joint between the blood filters and tubing |
| Nov 20, 2019 | Class II | Z-0937-2020 | Nonconforming Material/Component | Potential for leakage at the joint between the blood filters and tubing |
The 5 latest of 21 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 2 companies; a new generation was cleared every 5.8 years on median.
- 3 of the 4 ancestors have a recall of any class.
- Of its descendants, K212842 (B.Braun Medical, Inc., 2022) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K083723.
How does its category compare?
All FPA devicesFPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Caresite Luer Access Device is a valve intended for the aspiration, injection or gravity/pump flow of IV fluids and blood upon insertion of a male luer connector. The Caresite Luer Access Device may be used with power injectors at a maximum pressure of 400 psi and a maximum flow rate of 15 mL/sec.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140311 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140311: Caresite Luer Access Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140311
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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