510(k) · Cleared
ClearedMedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV Catheter
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 9, 2026 as substantially equivalent to K213664 (B.Braun Medical, Inc., 2022) after a 142-day review. Its family tree reaches back 8 generations to 1980.
- Decided
- Jul 9, 2026
- Review
- 142 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K801941 (1980). 15 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK801941 Burron Microcath Intra. Cath. PlacementtBurron Medical Products, Inc. · 1980
- 7 generations backK982805 Introcan Safety IV CatheterB.Braun Medical, Inc. · 1999 · Recalled
- 6 generations backK021094 Introcan Safety IV CatheterB.Braun Medical, Inc. · 2002 · Recalled
- 5 generations backK111236 Introcan Safety (R) 3 Closed IV Catheter 18GA X 1-3/4 (45MM) and…B.Braun Melsungen AG · 2011 · Recalled
- 4 generations backK163358 Introcan Safety 3 Closed IV CatheterB.Braun Melsungen AG · 2017
- 3 generations backK182870 Introcan Safety 3 Closed IV CatheterB.Braun Medical, Inc. · 2019 · Recalled
- 2 generations backK192676 Introcan Safety 2 IV Catheter 18-24 gaugeB.Braun Medical, Inc. · 2020
- 1 generation backK213664 B. Braun Introcan Safety 2 IV CatheterB.Braun Medical, Inc. · 2022
- This deviceK260539 MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety…MedSource Labs, LLC · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K801941 | Burron Microcath Intra. Cath. Placementt | Burron Medical Products, Inc. | 1980 | — |
| −7 | K982805 | Introcan Safety IV Catheter | B.Braun Medical, Inc. | 1999 | 1 |
| −6 | K021094 | Introcan Safety IV Catheter | B.Braun Medical, Inc. | 2002 | 1 |
| −5 | K111236 | Introcan Safety (R) 3 Closed IV Catheter 18GA X 1-3/4 (45MM) and 18GA X 1-1/4… | B.Braun Melsungen AG | 2011 | 1 |
| −4 | K163358 | Introcan Safety 3 Closed IV Catheter | B.Braun Melsungen AG | 2017 | — |
| −3 | K182870 | Introcan Safety 3 Closed IV Catheter | B.Braun Medical, Inc. | 2019 | 1 |
| −2 | K192676 | Introcan Safety 2 IV Catheter 18-24 gauge | B.Braun Medical, Inc. | 2020 | — |
| −1 | K213664 | B. Braun Introcan Safety 2 IV Catheter | B.Braun Medical, Inc. | 2022 | — |
| 0 (this device) | K260539 | MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV Catheter | MedSource Labs, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 2 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 2 | 0 |
| 2004 | 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 |
|---|---|---|---|
| * | K213664 | B. Braun Introcan Safety 2 IV CatheterSummary page 5…-Term Less Than 30 Days Regulation Number: 21 CFR 880.5200 Product Code: FOZ Device Class: II 3. Predicate Device B. Braun Introcan Safety® 2 IV Catheter, cleared under K213664 (February 11, 2022). 4. Device Description The MedSource PurSafe™ and QuickSafe™ Safety IV Catheters are sterile, single-use, ov… | 2022 |
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 46 years and passes through 4 companies; a new generation was cleared every 4.4 years on median.
- 7 of the 15 ancestors have a recall of any class.
- 1 other device also cites its predicate K213664.
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 MedSource PurSafe 1.V. Safety Catheter, and the MedSource QuickSafe I.V. Safety Catheter are 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 as stated in the FDA summary.
https://510kreport.com/device/K260539 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260539: MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ 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/K260539
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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