510(k) · Cleared
Recalled · Class II · 2022Introcan Safety 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 Aug 28, 2002 as substantially equivalent to K982805 (B.Braun Medical, Inc., 1999) and 2 other predicates after a 170-day review. Its family tree reaches back 2 generations to 1980. 55 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 28, 2002
- Review
- 170 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 2 generations to K801941 (1980). 4 ancestors in all. 55 later devices descend from it, 8 citing it directly.
- Root · 2 generations backK801941 Burron Microcath Intra. Cath. PlacementtBurron Medical Products, Inc. · 1980
- 1 generation backK982805 Introcan Safety IV CatheterB.Braun Medical, Inc. · 1999 · Recalled
- This deviceK020785 Introcan Safety IV CatheterB.Braun Medical, Inc. · 2002
- Descendant · cites it directly · 25 of its ownK101422 The Power Wand Safety Introducer with an Extended Dwell CatheterAccess Scientific, Inc. · 2011
- Descendant · 2 generations on · 19 of its ownK121073 Powerglide Midline CatheterC.R. Bard, Inc. · 2012 · Recalled
- Descendant · cites it directly · 15 of its ownK111236 Introcan Safety (R) 3 Closed IV Catheter 18GA X 1-3/4 (45MM) and…B.Braun Melsungen AG · 2011 · Recalled
- Descendant · 3 generations on · 12 of its ownK133856 Powerglide Midline CatheterC.R. Bard, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 9 of its ownK163358 Introcan Safety 3 Closed IV CatheterB.Braun Melsungen AG · 2017
Showing 5 of 55 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 55 · See all- K101422The Power Wand Safety Introducer with an Extended Dwell CatheterAccess Scientific, Inc. · 2011 · cites it directly25descendants
- K121073Powerglide Midline CatheterC.R. Bard, Inc. · 2012 · 2 generations on19descendants
- K111236Introcan Safety (R) 3 Closed IV Catheter 18GA X 1-3/4 (45MM) and 18GA X 1-1/4 (32MM) /…B.Braun Melsungen AG · 2011 · cites it directly15descendants
- K133856Powerglide Midline CatheterC.R. Bard, Inc. · 2014 · 3 generations on12descendants
- K163358Introcan Safety 3 Closed IV CatheterB.Braun Melsungen AG · 2017 · 2 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K801941 | Burron Microcath Intra. Cath. Placementt | Burron Medical Products, Inc. | 1980 | — |
| −1 | K982805 | Introcan Safety IV Catheter | B.Braun Medical, Inc. | 1999 | 1 |
| 0 (this device) | K020785 | Introcan Safety IV Catheter | B.Braun Medical, Inc. | 2002 | — |
| +1 | K101422 | The Power Wand Safety Introducer with an Extended Dwell Catheter | Access Scientific, Inc. | 2011 | — |
| +2 | K121073 | Powerglide Midline Catheter | C.R. Bard, Inc. | 2012 | 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 |
| +3 | K133856 | Powerglide Midline Catheter | C.R. Bard, Inc. | 2014 | 1 |
| +2 | K163358 | Introcan Safety 3 Closed IV Catheter | B.Braun Melsungen AG | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 4 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 2 | 0 |
| 2016 | 4 | 0 |
| 2017 | 4 | 0 |
| 2019 | 2 | 0 |
| 2020 | 4 | 0 |
| 2021 | 3 | 0 |
| 2022 | 7 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 4 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K982805 | Introcan Safety IV CatheterSummary page 1…880.5440: Intravascular Administration Set PREDICATE DEVICE: B. Braun Medical Inc. Introcan Safety IV Catheter, K982805. Johnson and Johnson JELCOTM,JELCO-WTMand JELCO Plus ITM,K990236… | 1999 |
| * | K990236 | Modification of Jelco*,Jelco*-W and Jelco* Plus I.V. Catheters, Cathlon* I.V. Catheters…Summary page 1…Introcan Safety IV Catheter, K982805. Johnson and Johnson JELCOTM,JELCO-WTMand JELCO Plus ITM,K990236 Becton Dickinson INSYTEB, INSYTE-WB and INSYTE B AUTOGUARD I1 catheters, K97 1339 DESCRIPT… | 1999 |
| * | K971339 | Insyte, Insyte-W, Insyte Autoguard CathetersSummary page 1…JELCOTM,JELCO-WTMand JELCO Plus ITM,K990236 Becton Dickinson INSYTEB, INSYTE-WB and INSYTE B AUTOGUARD I1 catheters, K97 1339 DESCRIPTION: B. Braun Medical’s Introcan Safety IV Catheter is a passive needle stick preve… | 1997 |
What descends from it? (55)
See all 558 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101422 | The Power Wand Safety Introducer with an Extended Dwell Catheter | 2011 | 25 |
| K111236 | Introcan Safety (R) 3 Closed IV Catheter 18GA X 1-3/4 (45MM) and 18GA X 1-1/4 (32MM) /… | 2011 | 15 |
| K082362 | Surshield Safety I.V. Catheter | 2008 | 5 |
| K080140 | Laurimed Spinal Injection System | 2008 | 2 |
| K231401 | Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva | 2023 | 1 |
| K220626 | Introcan Safety IV Catheter | 2022 | 1 |
| K210037 | Pluski Safe 1 Safety IV Catheter | 2022 | 0 |
| K161681 | Nipro SafeTouch IV Catheter | 2017 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 1, 2022 | Class II | Z-0009-2023 | Process control | Potential for leakage at the catheter hub. |
| Mar 19, 2004 | Not classified | Z-1092-04 | Other | Mislabeled product. The recalling firm received a complaint that a box of Introcan Safety Catheters, (22G x 1 inch) contained mixed 18G catheters with the same lot number. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 2 companies; a new generation was cleared every 18.4 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K101422 (Access Scientific, Inc., 2011) has gone furthest, with 25 descendants of its own.
- 4 other devices also cite its predicate K982805.
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.
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?
Passive anti-needle stick devices for venous or arterial access for the infusion of fluids, drugs, and/or blood components. 14 - 22 gauge catheters may be used with power injectors for which the maximum pressure setting is 300 psi.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K020785 · printed Nov 4, 2026
Cite this page
510(k) Report. “K020785: Introcan Safety IV Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K020785
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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