510(k) · Cleared
ClearedBD Onecath
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton Dickinson Infusion Therapy Systems, Inc. · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on Dec 3, 2004 after a 49-day review. The FDA summary names its predicate without a number. 26 later devices descend from it.
- Decided
- Dec 3, 2004
- Review
- 49 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- None
- Predicates
- 0
26 later devices descend from it, 1 citing it directly.
- This deviceK042862 BD OnecathBecton Dickinson Infusion Therapy Systems, Inc. · 2004
- 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 · 3 generations on · 12 of its ownK133856 Powerglide Midline CatheterC.R. Bard, Inc. · 2014 · Recalled
- Descendant · 4 generations on · 5 of its ownK153280 PowerGlide Pro Midline CatheterC.R. Bard, Inc. · 2016
- Descendant · 4 generations on · 5 of its ownK150407 BioFlo Midline CatheterNavilyst Medical, Inc. · 2015
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · 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
- K133856Powerglide Midline CatheterC.R. Bard, Inc. · 2014 · 3 generations on12descendants
- K153280PowerGlide Pro Midline CatheterC.R. Bard, Inc. · 2016 · 4 generations on5descendants
- K150407BioFlo Midline CatheterNavilyst Medical, Inc. · 2015 · 4 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K042862 | BD Onecath | Becton Dickinson Infusion Therapy Systems, Inc. | 2004 | — |
| +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 |
| +3 | K133856 | Powerglide Midline Catheter | C.R. Bard, Inc. | 2014 | 1 |
| +4 | K153280 | PowerGlide Pro Midline Catheter | C.R. Bard, Inc. | 2016 | — |
| +4 | K150407 | BioFlo Midline Catheter | Navilyst Medical, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 4 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | — | BD L-Cath Midline Catheter Named without a submission number |
What descends from it? (26)
See all 261 later device cites 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 |
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, K101422 (Access Scientific, Inc., 2011) has gone furthest, with 25 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?
The BD OneCathTM midline catheter is inserted into a patient's vascular system for short-term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids. This intravascular catheter may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042862 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042862: BD Onecath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042862
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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