510(k) · Cleared
ClearedClearSafe Closed System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
MedSource Labs, LLC · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on Jul 10, 2026 as substantially equivalent to K243403 (Becton Dickinson Infusion Therapy Systems, Inc., 2025) after a 101-day review. Its family tree reaches back 9 generations to 1995.
- Decided
- Jul 10, 2026
- Review
- 101 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K942988 (1995). 23 ancestors in all, the oldest K950301 (1995). No later device cites it as a predicate yet.
- Root · 9 generations backK942988 Filtered Extension SetsB. Braun of America, Inc. · 1995 · Recalled
- 5 generations between
- 3 generations backK170336 BD Nexiva Closed IV Catheter System (Single Port) with MaxZero…Becton, Dickinson and Company · 2017
- 2 generations backK183399 BD Nexiva Closed IV Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc. · 2019 · Recalled
- 1 generation backK243403 BD Nexiva™ Closed IV Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc. · 2025
- This deviceK261041 ClearSafe Closed SystemMedSource Labs, LLC · 2026
Show all 9 generations
- Root · 9 generations backK942988 Filtered Extension SetsB. Braun of America, Inc. · 1995 · Recalled
- 8 generations backK955585 V2 Injection SiteB.Braun Medical, Inc. · 1996 · Recalled
- 7 generations backK973167 Positive Pressure ConnectorIcu Medical, Inc. · 1997
- 6 generations backK021692 CLC2000 Catheter Patency DeviceIcu Medical, Inc. · 2003
- 5 generations backK100434 Clave NeutronIcu Medical, Inc. · 2010 · Recalled
- 4 generations backK132413 MZ1000Care Fusion · 2013
- 3 generations backK170336 BD Nexiva Closed IV Catheter System (Single Port) with MaxZero…Becton, Dickinson and Company · 2017
- 2 generations backK183399 BD Nexiva Closed IV Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc. · 2019 · Recalled
- 1 generation backK243403 BD Nexiva™ Closed IV Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc. · 2025
- This deviceK261041 ClearSafe Closed SystemMedSource Labs, LLC · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K942988 | Filtered Extension Sets | B. Braun of America, Inc. | 1995 | 32 |
| −8 | K955585 | V2 Injection Site | B.Braun Medical, Inc. | 1996 | 27 |
| −7 | K973167 | Positive Pressure Connector | Icu Medical, Inc. | 1997 | — |
| −6 | K021692 | CLC2000 Catheter Patency Device | Icu Medical, Inc. | 2003 | — |
| −5 | K100434 | Clave Neutron | Icu Medical, Inc. | 2010 | 3 |
| −4 | K132413 | MZ1000 | Care Fusion | 2013 | — |
| −3 | K170336 | BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless… | Becton, Dickinson and Company | 2017 | — |
| −2 | K183399 | BD Nexiva Closed IV Catheter System | Becton Dickinson Infusion Therapy Systems, Inc. | 2019 | 3 |
| −1 | K243403 | BD Nexiva™ Closed IV Catheter System | Becton Dickinson Infusion Therapy Systems, Inc. | 2025 | — |
| 0 (this device) | K261041 | ClearSafe Closed System | MedSource Labs, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 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 FOZ? 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 FOZ device
- #1 K243403 BD Nexiva™ Closed IV Catheter Systemscore 14.8 · 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 |
|---|---|---|---|
| * | K243403 | BD Nexiva™ Closed IV Catheter SystemSummary page 5…herapeutic, Short-Term Less Than 30 Days Classification Name: Intravascular catheter Regulation Number: 21 CFR 880.5200 Product Code: FOZ Device Class: II 510(k) Number: K243403 Sponsor: Becton, Dickinson and Company (BD) 4. Device Description The ClearSafe Closed System is a range of over-needle peripher… | 2025 |
What descends from it?
No later submission names this one as a predicate yet.
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 31 years and passes through 7 companies; a new generation was cleared every 3.1 years on median.
- 11 of the 23 ancestors have a recall of any class.
How does its category compare?
All FOZ devicesFOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · FOZ
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FOZ
91in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FOZ
4in 2023
Class I (5 since 2007) Class II/III not classified
Adverse event reports per year · FOZ
5,110in 2025
MAUDE reports naming product code FOZ, 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 | 6 | 159 | 16 | 374 |
| 2008 | 9 | 103 | 0 | 422 |
| 2009 | 9 | 30 | 23 | 508 |
| 2010 | 3 | 28 | 115 | 370 |
| 2011 | 6 | 132 | 0 | 786 |
| 2012 | 13 | 122 | 0 | 560 |
| 2013 | 4 | 104 | 2 | 640 |
| 2014 | 9 | 99 | 4 | 815 |
| 2015 | 10 | 107 | 0 | 729 |
| 2016 | 9 | 63 | 3 (1) | 925 |
| 2017 | 9 | 51 | 22 | 1,966 |
| 2018 | 1 | — | 4 | 3,305 |
| 2019 | 8 | 140 | 3 | 4,365 |
| 2020 | 10 | 191 | 3 | 3,797 |
| 2021 | 4 | 242 | 1 | 4,674 |
| 2022 | 8 | 183 | 4 (2) | 4,133 |
| 2023 | 9 | 129 | 4 (2) | 4,430 |
| 2024 | 6 | 190 | 0 | 4,772 |
| 2025 | 11 | 91 | 0 | 5,110 |
| 2026 | 7 | 203 | 2 | — |
What is it indicated for?
The ClearSafe Closed System is indicated to be inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravascularly. The catheters may be used intravascularly with power injectors at a maximum pressure of 325 psi with a Luer lock connection only
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/K261041 · printed Nov 4, 2026
Cite this page
510(k) Report. “K261041: ClearSafe Closed System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K261041
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026