510(k) · Cleared
Recalled · Class II · 2025Introcan Safety (R) 3 Closed IV Catheter 18GA X 1-3/4 (45MM) and 18GA X 1-1/4 (32MM) / 20GA X 1-1/4 (32MM) / 20GA X 1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
B.Braun Melsungen AG · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on Aug 30, 2011 as substantially equivalent to K021094 (B.Braun Medical, Inc., 2002) and 2 other predicates after a 120-day review. Its family tree reaches back 3 generations to 1980. 15 later devices descend from it. It has been recalled once.
- Decided
- Aug 30, 2011
- Review
- 120 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 3 generations to K801941 (1980). 10 ancestors in all. 15 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK801941 Burron Microcath Intra. Cath. PlacementtBurron Medical Products, Inc. · 1980
- 2 generations backK982805 Introcan Safety IV CatheterB.Braun Medical, Inc. · 1999 · Recalled
- 1 generation backK021094 Introcan Safety IV CatheterB.Braun Medical, Inc. · 2002 · Recalled
- This deviceK111236 Introcan Safety (R) 3 Closed IV Catheter 18GA X 1-3/4 (45MM) and…B.Braun Melsungen AG · 2011
- Descendant · cites it directly · 9 of its ownK163358 Introcan Safety 3 Closed IV CatheterB.Braun Melsungen AG · 2017
- Descendant · cites it directly · 8 of its ownK182870 Introcan Safety 3 Closed IV CatheterB.Braun Medical, Inc. · 2019 · Recalled
- Descendant · 2 generations on · 6 of its ownK192676 Introcan Safety 2 IV Catheter 18-24 gaugeB.Braun Medical, Inc. · 2020
- Descendant · cites it directly · 4 of its ownK172506 BD Cathena Safety IV CatheterBecton, Dickinson and Company · 2017
- Descendant · 3 generations on · 3 of its ownK213664 B. Braun Introcan Safety 2 IV CatheterB.Braun Medical, Inc. · 2022
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K163358Introcan Safety 3 Closed IV CatheterB.Braun Melsungen AG · 2017 · cites it directly9descendants
- K182870Introcan Safety 3 Closed IV CatheterB.Braun Medical, Inc. · 2019 · cites it directly8descendants
- K192676Introcan Safety 2 IV Catheter 18-24 gaugeB.Braun Medical, Inc. · 2020 · 2 generations on6descendants
- K172506BD Cathena Safety IV CatheterBecton, Dickinson and Company · 2017 · cites it directly4descendants
- K213664B. Braun Introcan Safety 2 IV CatheterB.Braun Medical, Inc. · 2022 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K801941 | Burron Microcath Intra. Cath. Placementt | Burron Medical Products, Inc. | 1980 | — |
| −2 | K982805 | Introcan Safety IV Catheter | B.Braun Medical, Inc. | 1999 | 1 |
| −1 | K021094 | Introcan Safety IV Catheter | B.Braun Medical, Inc. | 2002 | 1 |
| 0 (this device) | 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 | K163358 | Introcan Safety 3 Closed IV Catheter | B.Braun Melsungen AG | 2017 | — |
| +1 | 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 | K172506 | BD Cathena Safety IV Catheter | Becton, Dickinson and Company | 2017 | — |
| +3 | K213664 | B. Braun Introcan Safety 2 IV Catheter | B.Braun Medical, Inc. | 2022 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K021094 | Introcan Safety IV CatheterSummary page 1…Class 11, per 21 CFll §880.5200: Intravascular Catheter PREDICATE DEVICES: Introcan Safety® IV'rh Catheter, B. Braun Medical, Inc., K02 1094 and K020785, Class 11, DYB and FOZ, 880.5200: Intravascular Catheter Nexiva"… | 2002 |
| * | K020785 | Introcan Safety IV CatheterSummary page 1…Class 11, per 21 CFll §880.5200: Intravascular Catheter PREDICATE DEVICES: Introcan Safety® IV'rh Catheter, B. Braun Medical, Inc., K02 1094 and K020785, Class 11, DYB and FOZ, 880.5200: Intravascular Catheter Nexiva"'m Closed IV… | 2002 |
| * | K032843 | Nexiva Closed IV Catheter SystemSummary page 1…5200: Intravascular Catheter Nexiva"'m Closed IV Catheter System, Becton Dickinson, K032843, Class II, FOZ, 880.5200: Intravascular Catheter DESCRIPTION: The Introcan Safety® 3 Closed IV Catheter consi… | 2004 |
What descends from it? (15)
See all 153 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 17, 2025 | Class II | Z-1397-2025 | Process control | Increased risk for valve housing detachment causing leakage. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 31 years and passes through 3 companies; a new generation was cleared every 9.2 years on median.
- 5 of the 10 ancestors have a recall of any class.
- Of its descendants, K163358 (B.Braun Melsungen AG, 2017) has gone furthest, with 9 descendants of its own.
- 2 other devices also cite its predicate K021094.
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. 2011, 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 Safetrs 3 Closed Intravascular Catheter is inserted into a patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure or administer fluids and blood intravascularly.
The 18-22 gauge catheters may be used with power injectors at a maximum pressure of 300 psi with a luer lock connection only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111236 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111236: Introcan Safety (R) 3 Closed IV Catheter 18GA X 1-3/4 (45MM) and 18GA X 1-1/4 (32MM) / 20GA X 1-1/4 (32MM) / 20GA X 1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111236
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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