510(k) · Cleared
ClearedIntrocan Safety 3 Closed IV Catheter
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 Apr 28, 2017 as substantially equivalent to K111236 (B.Braun Melsungen AG, 2011) after a 149-day review. Its family tree reaches back 4 generations to 1980. 9 later devices descend from it.
- Decided
- Apr 28, 2017
- Review
- 149 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K801941 (1980). 11 ancestors in all. 9 later devices descend from it, 1 citing it directly.
- 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 backK021094 Introcan Safety IV CatheterB.Braun Medical, Inc. · 2002 · Recalled
- 1 generation backK111236 Introcan Safety (R) 3 Closed IV Catheter 18GA X 1-3/4 (45MM) and…B.Braun Melsungen AG · 2011 · Recalled
- This deviceK163358 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 · 3 generations on · 3 of its ownK213664 B. Braun Introcan Safety 2 IV CatheterB.Braun Medical, Inc. · 2022
- Descendant · 3 generations on · 1 of its ownK231401 Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety AdvaPoly Medicure Limited · 2023
- Descendant · 4 generations on · 1 of its ownK220756 Introcan Safety 2 IV CatheterB.Braun Medical, Inc. · 2022
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- 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
- K213664B. Braun Introcan Safety 2 IV CatheterB.Braun Medical, Inc. · 2022 · 3 generations on3descendants
- K231401Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety AdvaPoly Medicure Limited · 2023 · 3 generations on1descendant
- K220756Introcan Safety 2 IV CatheterB.Braun Medical, Inc. · 2022 · 4 generations on1descendant
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 | K021094 | Introcan Safety IV Catheter | B.Braun Medical, Inc. | 2002 | 1 |
| −1 | 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 |
| 0 (this device) | 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 | — |
| +3 | K213664 | B. Braun Introcan Safety 2 IV Catheter | B.Braun Medical, Inc. | 2022 | — |
| +3 | K231401 | Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva | Poly Medicure Limited | 2023 | — |
| +4 | K220756 | 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 |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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? (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 |
|---|---|---|---|
| * | K111236 | Introcan Safety (R) 3 Closed IV Catheter 18GA X 1-3/4 (45MM) and 18GA X 1-1/4 (32MM) /…Summary page 4…heter Product Code FOZ PREDICATE DEVICE: Introcan Safety® 3 Closed IV Catheter B. Braun Medical Inc., K111236 General Hospital, Class II, per 21 CFR §880.5200 Intravascular Catheter SUBJEC… | 2011 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182870 | Introcan Safety 3 Closed IV Catheter | 2019 | 8 |
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 37 years and passes through 3 companies; a new generation was cleared every 9.2 years on median.
- 6 of the 11 ancestors have a recall of any class.
- Of its descendants, K182870 (B.Braun Medical, Inc., 2019) has gone furthest, with 8 descendants of its own.
- 2 other devices also cite its predicate K111236.
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. 2017, 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® 3 Closed Intravascular Catheter is inserted into a patient's vascular system for short term use to sample blood, monitor blood pressure or administer fluids and blood intravascularly.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163358 · printed Nov 5, 2026
Cite this page
510(k) Report. “K163358: Introcan Safety 3 Closed IV Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K163358
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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