510(k) · Decided
DecidedDual Lumen 5 FR Perip Cent Ven Cath W/Groshong Val
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Davol, Inc. · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on Feb 11, 1991 after a 129-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 of the 55 devices in its family, counting itself, have a Class I recall. 54 later devices descend from it.
- Decided
- Feb 11, 1991
- Review
- 129 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- None
- Predicates
- 0
54 later devices descend from it, 1 citing it directly. 7 of the 55 devices in this family, counting this one, have a Class I recall.
- This deviceK904558 Dual Lumen 5 FR Perip Cent Ven Cath W/Groshong ValDavol, Inc. · 1991
- Descendant · cites it directly · 53 of its ownK023374 Groshong NXT Dual Lumen Picc CathetersC.R. Bard, Inc. · 2002 · Recalled
- Descendant · 2 generations on · 43 of its ownK060341 Sherlock Tip Location System (TLS)C.R. Bard, Inc. · 2006
- Descendant · 3 generations on · 42 of its ownK063240 Sherlock TLS Stylet, Sherlock TLS DetectorC.R. Bard, Inc. · 2006 · Recalled
- Descendant · 4 generations on · 40 of its ownK081625 Flowpicc StyletVasonova, Inc. · 2008
- Descendant · 4 generations on · 39 of its ownK081626 Flowpicc ConsoleVasonova, Inc. · 2008
Showing 5 of 54 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 54 · See all- K023374Groshong NXT Dual Lumen Picc CathetersC.R. Bard, Inc. · 2002 · cites it directly53descendants
- K060341Sherlock Tip Location System (TLS)C.R. Bard, Inc. · 2006 · 2 generations on43descendants
- K063240Sherlock TLS Stylet, Sherlock TLS DetectorC.R. Bard, Inc. · 2006 · 3 generations on42descendants
- K081625Flowpicc StyletVasonova, Inc. · 2008 · 4 generations on40descendants
- K081626Flowpicc ConsoleVasonova, Inc. · 2008 · 4 generations on39descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K904558 | Dual Lumen 5 FR Perip Cent Ven Cath W/Groshong Val | Davol, Inc. | 1991 | — |
| +1 | K023374 | Groshong NXT Dual Lumen Picc Catheters | C.R. Bard, Inc. | 2002 | 5 |
| +2 | K060341 | Sherlock Tip Location System (TLS) | C.R. Bard, Inc. | 2006 | — |
| +3 | K063240 | Sherlock TLS Stylet, Sherlock TLS Detector | C.R. Bard, Inc. | 2006 | 18 |
| +4 | K081625 | Flowpicc Stylet | Vasonova, Inc. | 2008 | — |
| +4 | K081626 | Flowpicc Console | Vasonova, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 1 |
| 2013 | 5 | 2 |
| 2014 | 5 | 0 |
| 2015 | 5 | 0 |
| 2016 | 5 | 3 |
| 2017 | 3 | 0 |
| 2018 | 3 | 0 |
| 2021 | 3 | 1 |
| 2022 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 4 | 0 |
| 2026 | 1 | 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.
7 devices in this family have a Class I recall. 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? (54)
See all 541 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K023374 | Groshong NXT Dual Lumen Picc Catheters | 2002 | 53 |
Has anything in its family been recalled? (7 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K210264BD PowerPiCC CatheterBard Access Systems, Inc. · 2021 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
- K122545CG+ Arrow Picc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.) · 2012 · 6 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K132133CG+ Arrow Jacc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.) · 2013 · 6 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K130876CG+ Arrow Picc Powered by Arrow VPS StyletArrow International, Inc. · 2013 · 7 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K153423CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACCArrow International, Inc. (Subsidiary of Teleflex, Inc.) · 2016 · 7 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K153487CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUSArrow International, Inc. (Subsidiary of Teleflex, Inc.) · 2016 · 7 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K160925VPS Rhythm Device with TipTracker TechnologyArrow International, Inc. (A Subsidiary of Teleflex, Inc.) · 2016 · 8 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
Nearest 5 of 7; all are on the web page.
What does this lineage say?
- Of its descendants, K023374 (C.R. Bard, Inc., 2002) has gone furthest, with 53 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/K904558 · printed Nov 4, 2026
Cite this page
510(k) Report. “K904558: Dual Lumen 5 FR Perip Cent Ven Cath W/Groshong Val.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K904558
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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