510(k) · Cleared
ClearedIntrocan Safety® Deep Access XL IV Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
B.Braun Medical, Inc. · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on May 15, 2026 as substantially equivalent to K220626 (B.Braun Medical, Inc., 2022) after a 228-day review. Its family tree reaches back 4 generations to 1980.
- Decided
- May 15, 2026
- Review
- 228 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K801941 (1980). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK801941 Burron Microcath Intra. Cath. PlacementtBurron Medical Products, Inc. · 1980
- 3 generations backK982805 Introcan Safety IV CatheterB.Braun Medical, Inc. · 1999 · Recalled
- 2 generations backK020785 Introcan Safety IV CatheterB.Braun Medical, Inc. · 2002 · Recalled
- 1 generation backK220626 Introcan Safety IV CatheterB.Braun Medical, Inc. · 2022
- This deviceK253235 Introcan Safety® Deep Access XL IV CatheterB.Braun Medical, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K801941 | Burron Microcath Intra. Cath. Placementt | Burron Medical Products, Inc. | 1980 | — |
| −3 | K982805 | Introcan Safety IV Catheter | B.Braun Medical, Inc. | 1999 | 1 |
| −2 | K020785 | Introcan Safety IV Catheter | B.Braun Medical, Inc. | 2002 | 2 |
| −1 | K220626 | Introcan Safety IV Catheter | B.Braun Medical, Inc. | 2022 | — |
| 0 (this device) | K253235 | Introcan Safety® Deep Access XL IV Catheter | B.Braun Medical, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 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 |
|---|---|---|---|
| * | K220626 | Introcan Safety IV CatheterSummary page 5…Less than 30 Days Therapeutic Intravascular Catheter Classification Name: Intravascular catheter, 21 CFR §880.5200: Class II, Product code FOZ PREDICATE DEVICE: • K220626. Introcan Safety® IV Catheter, B. Braun Medical, Inc. DEVICE DESCRIPTION The Introcan Safety® Deep Access XL Catheter are steril… | 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 2 companies; a new generation was cleared every 18.4 years on median.
- 3 of the 6 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?
Introcan Safety® Deep Access XL IV Catheter is a passive anti-needlestick device to provide venous or arterial access for the infusion of fluids, drugs, and or blood components, or to facilitate the placement of Vascular Access devices into the vascular system. The catheters may be used 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/K253235 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253235: Introcan Safety® Deep Access XL 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/K253235
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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