510(k) · Cleared
ClearedInsyte, Insyte-W, Insyte Autoguard Catheters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton Dickinson Vascular Access, Inc. · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on Dec 24, 1997 after a 258-day review. The FDA summary names its predicate without a number. 63 later devices descend from it.
- Decided
- Dec 24, 1997
- Review
- 258 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- None
- Predicates
- 0
63 later devices descend from it, 6 citing it directly.
- This deviceK971339 Insyte, Insyte-W, Insyte Autoguard CathetersBecton Dickinson Vascular Access, Inc. · 1997
- Descendant · cites it directly · 55 of its ownK020785 Introcan Safety IV CatheterB.Braun Medical, Inc. · 2002 · Recalled
- Descendant · 2 generations on · 25 of its ownK101422 The Power Wand Safety Introducer with an Extended Dwell CatheterAccess Scientific, Inc. · 2011
- Descendant · 3 generations on · 19 of its ownK121073 Powerglide Midline CatheterC.R. Bard, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 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 · 4 generations on · 12 of its ownK133856 Powerglide Midline CatheterC.R. Bard, Inc. · 2014 · Recalled
Showing 5 of 63 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 63 · See all- K020785Introcan Safety IV CatheterB.Braun Medical, Inc. · 2002 · cites it directly55descendants
- K101422The Power Wand Safety Introducer with an Extended Dwell CatheterAccess Scientific, Inc. · 2011 · 2 generations on25descendants
- K121073Powerglide Midline CatheterC.R. Bard, Inc. · 2012 · 3 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 · 2 generations on15descendants
- K133856Powerglide Midline CatheterC.R. Bard, Inc. · 2014 · 4 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K971339 | Insyte, Insyte-W, Insyte Autoguard Catheters | Becton Dickinson Vascular Access, Inc. | 1997 | — |
| +1 | K020785 | Introcan Safety IV Catheter | B.Braun Medical, Inc. | 2002 | 2 |
| +2 | K101422 | The Power Wand Safety Introducer with an Extended Dwell Catheter | Access Scientific, Inc. | 2011 | — |
| +3 | K121073 | Powerglide Midline Catheter | C.R. Bard, Inc. | 2012 | 1 |
| +2 | 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 | K133856 | Powerglide Midline Catheter | C.R. Bard, Inc. | 2014 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 5 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 5 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 3 | 0 |
| 2016 | 5 | 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? (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 |
|---|---|---|---|
| * | — | Becton Dickinson Vascular Access INSYTE®, INSYTE-W®, and INSYTE® AUTOGUARD™ brand… Named without a submission number |
What descends from it? (63)
See all 636 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K020785 | Introcan Safety IV Catheter | 2002 | 55 |
| K991406 | Terumo Surflo Flex I.V. Catheter and Terumo Surflash I.V. Catheter | 1999 | 9 |
| K122544 | Terumo Surflash Safety I.V. Catheter | 2012 | 1 |
| K120839 | Novacath Secure IV Catheter System-18G | 2012 | 1 |
| K123267 | Surfflash (R) Plus Safety I.V. Catheter | 2012 | 0 |
| K073471 | Vantagecath Intravascular Catheter | 2008 | 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?
- Of its descendants, K020785 (B.Braun Medical, Inc., 2002) has gone furthest, with 55 descendants of its own.
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?
As indicated in 21 CFR 870.1200, to sample blood, to monitor blood pressure, or to introduce substances into the heart and vessels. These 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 catheters may be used with power injectors for which the maximum rated pressure is 300 psi.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971339 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971339: Insyte, Insyte-W, Insyte Autoguard Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971339
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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