510(k) · Cleared
ClearedAngiocath & 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 Jul 31, 1995 after a 39-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Jul 31, 1995
- Review
- 39 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK952861 Angiocath & Insyte Autoguard CathetersBecton Dickinson Vascular Access, Inc. · 1995
- Descendant · cites it directly · 2 of its ownK223018 OSPREY PERIPHERAL IV Catheter SystemSkydance Vascular, Inc. · 2023
- Descendant · 2 generations on · 1 of its ownK231626 OSPREY Closed IV Catheter System (OspreyV2)Skydance Vascular, Inc. · 2023
- Descendant · cites it directly · 1 of its ownK201075 BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC…Becton, Dickinson and Company · 2020 · Recalled
- Descendant · 2 generations on · 0 of its ownK251654 BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC…Becton Dickinson Infusion Therapy Systems, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK250292 OSPREY Midline Closed IV Catheter System (OspreyEDC-F20)Skydance Vascular, Inc. · 2025
Most influential descendants
Showing 5 of 5 · See all- K223018OSPREY PERIPHERAL IV Catheter SystemSkydance Vascular, Inc. · 2023 · cites it directly2descendants
- K231626OSPREY Closed IV Catheter System (OspreyV2)Skydance Vascular, Inc. · 2023 · 2 generations on1descendant
- K201075BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter…Becton, Dickinson and Company · 2020 · cites it directly1descendant
- K251654BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV…Becton Dickinson Infusion Therapy Systems, Inc. · 2025 · 2 generations on0descendants
- K250292OSPREY Midline Closed IV Catheter System (OspreyEDC-F20)Skydance Vascular, Inc. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K952861 | Angiocath & Insyte Autoguard Catheters | Becton Dickinson Vascular Access, Inc. | 1995 | — |
| +1 | K223018 | OSPREY PERIPHERAL IV Catheter System | Skydance Vascular, Inc. | 2023 | — |
| +2 | K231626 | OSPREY Closed IV Catheter System (OspreyV2) | Skydance Vascular, Inc. | 2023 | — |
| +1 | K201075 | BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV… | Becton, Dickinson and Company | 2020 | 11 |
| +2 | K251654 | BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded… | Becton Dickinson Infusion Therapy Systems, Inc. | 2025 | — |
| +3 | K250292 | OSPREY Midline Closed IV Catheter System (OspreyEDC-F20) | Skydance Vascular, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K223018 (Skydance Vascular, Inc., 2023) has gone furthest, with 2 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 | — |
https://510kreport.com/device/K952861 · printed Nov 6, 2026
Cite this page
510(k) Report. “K952861: Angiocath & Insyte Autoguard Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K952861
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026