510(k) · Cleared
ClearedPolysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Poly Medicure Limited · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on Sep 21, 2023 as substantially equivalent to K192676 (B.Braun Medical, Inc., 2020) and 1 other predicate after a 129-day review. Its family tree reaches back 7 generations to 1980. 1 later device descends from it.
- Decided
- Sep 21, 2023
- Review
- 129 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K801941 (1980). 14 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK801941 Burron Microcath Intra. Cath. PlacementtBurron Medical Products, Inc. · 1980
- 6 generations backK982805 Introcan Safety IV CatheterB.Braun Medical, Inc. · 1999 · Recalled
- 5 generations backK021094 Introcan Safety IV CatheterB.Braun Medical, Inc. · 2002 · Recalled
- 4 generations backK111236 Introcan Safety (R) 3 Closed IV Catheter 18GA X 1-3/4 (45MM) and…B.Braun Melsungen AG · 2011 · Recalled
- 3 generations backK163358 Introcan Safety 3 Closed IV CatheterB.Braun Melsungen AG · 2017
- 2 generations backK182870 Introcan Safety 3 Closed IV CatheterB.Braun Medical, Inc. · 2019 · Recalled
- 1 generation backK192676 Introcan Safety 2 IV Catheter 18-24 gaugeB.Braun Medical, Inc. · 2020
- This deviceK231401 Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety AdvaPoly Medicure Limited · 2023
- Descendant · cites it directly · 0 of its ownK252513 Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G…Poly Medicure Limited · 2026
Most influential descendants
Showing 1 of 1 · See all- K252513Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm…Poly Medicure Limited · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K801941 | Burron Microcath Intra. Cath. Placementt | Burron Medical Products, Inc. | 1980 | — |
| −6 | K982805 | Introcan Safety IV Catheter | B.Braun Medical, Inc. | 1999 | 1 |
| −5 | K021094 | Introcan Safety IV Catheter | B.Braun Medical, Inc. | 2002 | 1 |
| −4 | 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 |
| −3 | K163358 | Introcan Safety 3 Closed IV Catheter | B.Braun Melsungen AG | 2017 | — |
| −2 | K182870 | Introcan Safety 3 Closed IV Catheter | B.Braun Medical, Inc. | 2019 | 1 |
| −1 | K192676 | Introcan Safety 2 IV Catheter 18-24 gauge | B.Braun Medical, Inc. | 2020 | — |
| 0 (this device) | K231401 | Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva | Poly Medicure Limited | 2023 | — |
| +1 | K252513 | Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm… | Poly Medicure Limited | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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? (2)
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 |
|---|---|---|---|
| * | K192676 | Introcan Safety 2 IV Catheter 18-24 gaugeSummary page 4…Predicate Manufacturer: B. Braun Medical Inc. Predicate Trade Name: Introcan Safety® 2 IV Catheter Predicate 510(k) Number: K192676 Class II Predicate Product Code FOZ FDA Classification Name:… | 2020 |
| * | K020785 | Introcan Safety IV CatheterSummary page 4…Predicate Manufacturer: B. Braun Medical Inc Predicate Trade Name: Introcan Safety® IV Catheter Predicate 510(k) Number: K020785 Class II Predicate Product Code FOZ FDA Classification Name: 21 C… | 2002 |
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 |
|---|---|---|---|
| K252513 | Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm… | 2026 | 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 43 years and passes through 4 companies; a new generation was cleared every 3.5 years on median.
- 7 of the 14 ancestors have a recall of any class.
- Of its descendants, K252513 (Poly Medicure Limited, 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K192676.
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. 2023, 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 Polysafety BC IV Catheter are indicated for short-term use (less than 30 days) for insertion into a patient's vascular system to sample blood or administer fluids such as solutions, parenteral nutrition, and administration of other drugs. The catheters may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused and duration of therapy. The 18G-24G catheters may be used…
Read the full statement (317 words)
The Polysafety BC IV Catheter are indicated for short-term use (less than 30 days) for insertion into a patient's vascular system to sample blood or administer fluids such as solutions, parenteral nutrition, and administration of other drugs. The catheters may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused and duration of therapy. The 18G-24G catheters may be used intravascularly with power injectors at a maximum pressure of 300psi.
The Polysafety BC Adva IV Catheter are indicated for short-term use (less than 30 days) for insertion into a patient's vascular system to sample blood or administer fluids such as solutions, parenteral nutrition, and administration of other drugs. The catheters may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused and duration of therapy. The l 8G-24G catheters may be used intravascularly with power injectors at a maximum pressure of 300psi.
The Polywin Safety IV Catheter are indicated for short term use (less than 30 days) for insertion into a patient's vascular system to sample blood or administer fluids such as solutions, parenteral nutrition and administration of other drugs. The catheters may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused and duration of therapy. The 14G-24G catheters may be used intravascularly with power injectors at a maximum pressure of 300psi.
The Polywin Safety Adva IV Catheter are indicated for short term use (less than 30 days) for insertion into a patient's vascular system to sample blood or administer fluids such as solutions, parenteral nutrition and administration of other drugs. The catheters may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused and duration of therapy. The 14G-24G catheters may be used intravascularly with power injectors at a maximum pressure of 300psi.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231401 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231401: Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231401
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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