510(k) · Cleared
ClearedMedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV 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 Nov 3, 2016 as substantially equivalent to K131555 (Medsource International, LLC, 2014) after a 127-day review. Its family tree reaches back 2 generations to 1999. 1 later device descends from it.
- Decided
- Nov 3, 2016
- Review
- 127 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K984059 (1999). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK984059 Angiocath Autoguard Catheter, Insyte Autoguard CatheterBd Becton Dickinson Vacutainer Systems Preanalytic · 1999
- 1 generation backK131555 Medsource IV Safety CatheterMedsource International, LLC · 2014
- This deviceK161779 MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort…Medsource International, LLC · 2016
- Descendant · cites it directly · 0 of its ownK223788 The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the…Medsource International, LLC · 2023
Most influential descendants
Showing 1 of 1 · See all- K223788The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe…Medsource International, LLC · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K984059 | Angiocath Autoguard Catheter, Insyte Autoguard Catheter | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1999 | — |
| −1 | K131555 | Medsource IV Safety Catheter | Medsource International, LLC | 2014 | — |
| 0 (this device) | K161779 | MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV… | Medsource International, LLC | 2016 | — |
| +1 | K223788 | The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource… | Medsource International, LLC | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K131555 | Medsource IV Safety CatheterSummary page 4…Proprietary Name: MedSource TrueSafe Safety IV Catheter and MedSource TrueSafe Comfort Safety IV Catheter Predicate Device: MedSource IV Safety Catheter, K131555 Indications for Use: The MedSource TrueSafe Safety IV Catheter and the MedSource TrueSafe Comfort Safety IV Catheter is indicate… | 2014 |
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 |
|---|---|---|---|
| K223788 | The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe… | 2023 | 0 |
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 17 years and passes through 2 companies; a new generation was cleared every 14.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K223788 (Medsource International, LLC, 2023) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K131555.
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. 2016, 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 TrueSafe Safety IV Catheter and the MedSource TrueSafe Comfort Safety IV Catheter is indicated to sample blood or administer fluids intravenously. The MedSource TrueSafe Safety IV Catheter and the MedSource TrueSafe Comfort Safety IV 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/K161779 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161779: MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161779
Report an extraction error
Are you the manufacturer?
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