510(k) · Cleared
ClearedPolywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm; 22G x 45mm; 24G x 32mm; 24G x 14mm, 26G x 14mm); Polywin Safety Adva (20G x 45mm; 22G x 64mm; 22G x 45mm ; 24G x 32 mm; 24G x 14mm; 14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm, 26G x 14mm)
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 Apr 1, 2026 as substantially equivalent to K231401 (Poly Medicure Limited, 2023) after a 233-day review. Its family tree reaches back 8 generations to 1980.
- Decided
- Apr 1, 2026
- Review
- 233 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 backK231401 Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety AdvaPoly Medicure Limited · 2023
- This deviceK252513 Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G…Poly Medicure Limited · 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 | K231401 | Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva | Poly Medicure Limited | 2023 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K231401 | Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety AdvaSummary page 5…icate Manufacturer: Poly Medicure Ltd Predicate Trade Name: Polywin Safety and Polywin Safety Adva IV Catheter Predicate 510(k) Number: K231401 Class II Predicate Product Code FOZ FDA Classification N… | 2023 |
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 3.5 years on median.
- 7 of the 15 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?
The Polywin Safety and Polywin Safety Adva IV Catheters 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/K252513 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252513: Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm; 22G x 45mm; 24G x 32mm; 24G x 14mm, 26G x 14mm); Polywin Safety Adva (20G x 45mm; 22G x 64mm; 22G x 45mm ; 24G x 32 mm; 24G x 14mm; 14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm, 26G x 14mm).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252513
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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