510(k) · Cleared
ClearedMedsource IV Safety Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medsource International, LLC · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on Jan 31, 2014 as substantially equivalent to K984059 (Bd Becton Dickinson Vacutainer Systems Preanalytic, 1999) after a 247-day review. Its family tree reaches back 1 generation to 1999. 4 later devices descend from it.
- Decided
- Jan 31, 2014
- Review
- 247 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K984059 (1999). 4 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK984059 Angiocath Autoguard Catheter, Insyte Autoguard CatheterBd Becton Dickinson Vacutainer Systems Preanalytic · 1999
- This deviceK131555 Medsource IV Safety CatheterMedsource International, LLC · 2014
- Descendant · cites it directly · 1 of its ownK161779 MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort…Medsource International, LLC · 2016
- Descendant · 2 generations on · 0 of its ownK223788 The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the…Medsource International, LLC · 2023
- Descendant · cites it directly · 0 of its ownK193278 MedSource CathMED IV CatheterMedsource Labs · 2020
- Descendant · cites it directly · 0 of its ownK150611 MedSource ClearSafe Safety IV CatheterMedsource International · 2015
Most influential descendants
Showing 4 of 4 · See all- K161779MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV CatheterMedsource International, LLC · 2016 · cites it directly1descendant
- K223788The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe…Medsource International, LLC · 2023 · 2 generations on0descendants
- K193278MedSource CathMED IV CatheterMedsource Labs · 2020 · cites it directly0descendants
- K150611MedSource ClearSafe Safety IV CatheterMedsource International · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K984059 | Angiocath Autoguard Catheter, Insyte Autoguard Catheter | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1999 | — |
| 0 (this device) | K131555 | Medsource IV Safety Catheter | Medsource International, LLC | 2014 | — |
| +1 | K161779 | MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV… | Medsource International, LLC | 2016 | — |
| +2 | K223788 | The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource… | Medsource International, LLC | 2023 | — |
| +1 | K193278 | MedSource CathMED IV Catheter | Medsource Labs | 2020 | — |
| +1 | K150611 | MedSource ClearSafe Safety IV Catheter | Medsource International | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K984059 | Angiocath Autoguard Catheter, Insyte Autoguard CatheterSummary page 2…1 Yellow Description of the Device Design: The MedSource IV Safety Catheter is substantially equivalent to the Becton Dickinson Angiocath Autogaurd (K984059) Comparison Point Predicate Devices Result of Comparison Intended Use… | 1999 |
What descends from it? (4)
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 FOZ devicesFOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 MedSource IV Safety Catheter is indicated to sample blood, or administer fluids intravenously. The MedSource IV Safety Catheter may be used for any patient population with consideration given to adequacy for the vascular anatomy appropriateness for the solution being administered and duration of the therapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131555 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131555: Medsource IV Safety Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131555
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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