510(k) · Cleared
ClearedBD Acute Central Line
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bard Access Systems, Inc. (Bard Has Joined Bd) · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on Nov 1, 2019 as substantially equivalent to K071538 (Arrow International, Inc., 2007) after a 213-day review. Its family tree reaches back 9 generations to 2000. 4 of the 28 devices in its family, counting itself, have a Class I recall. 3 later devices descend from it.
- Decided
- Nov 1, 2019
- Review
- 213 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K001901 (2000). 24 ancestors in all, the oldest K830256 (1983). 3 later devices descend from it, 3 citing it directly. 4 of the 28 devices in this family, counting this one, have a Class I recall.
- Root · 9 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 5 generations between
- 3 generations backK051991 Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and…C.R. Bard, Inc. · 2005
- 2 generations backK061179 Powerhickman Long-Term Intravascular CatheterC.R. Bard, Inc. · 2006
- 1 generation backK071538 Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus Pressure Injectable…Arrow International, Inc. · 2007 · Recalled (Class I)
- This deviceK190855 BD Acute Central LineBard Access Systems, Inc. (Bard Has Joined Bd) · 2019
- Descendant · cites it directly · 0 of its ownK242429 CentroVena Central Venous Catheter (CVC) with the CentroVena One…Becton Dickinson Inc. (Bd) · 2025
- Descendant · cites it directly · 0 of its ownK221827 Mais Central Venous CatheterSaudi Mais Co. For Medical Products · 2023
- Descendant · cites it directly · 0 of its ownK200266 BD Centro Vena Acute Central Line (7 French Dual Lumen)Bard Access Systems, Inc. (Bard Has Joined Bd) · 2020
Show all 9 generations
- Root · 9 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 8 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
- 7 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
- 6 generations backK033389 Powerpicc Catheters, Models 3175155, 3175135C.R. Bard, Inc. · 2004 · Recalled
- 5 generations backK050185 Powerhohn and Powerline CathetersC.R. Bard, Inc. · 2005
- 4 generations backK051417 6 FR FL Powerhohn and Powerline CatheterC.R. Bard, Inc. · 2005 · Recalled
- 3 generations backK051991 Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and…C.R. Bard, Inc. · 2005
- 2 generations backK061179 Powerhickman Long-Term Intravascular CatheterC.R. Bard, Inc. · 2006
- 1 generation backK071538 Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus Pressure Injectable…Arrow International, Inc. · 2007 · Recalled (Class I)
- This deviceK190855 BD Acute Central LineBard Access Systems, Inc. (Bard Has Joined Bd) · 2019
Class I recalls in this family
- K071538 Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus…direct predicate · 2007
- K993691 Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen…2 generations back · 2000
- K900263 Antimicrobial Multi-Lumen Central Venous Catheter2 generations back · 1990
- K862056 [Central Venous][Multi-Lumen] Catheter W/Flex Tip2 generations back · 1986
Most influential descendants
Showing 3 of 3 · See all- K242429CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion SystemBecton Dickinson Inc. (Bd) · 2025 · cites it directly0descendants
- K221827Mais Central Venous CatheterSaudi Mais Co. For Medical Products · 2023 · cites it directly0descendants
- K200266BD Centro Vena Acute Central Line (7 French Dual Lumen)Bard Access Systems, Inc. (Bard Has Joined Bd) · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K001901 | Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline… | C.R. Bard, Inc. | 2000 | 2 |
| −8 | K012902 | Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath… | C.R. Bard, Inc. | 2001 | — |
| −7 | K031129 | Poly Per-Q-Cath Picc Catheters; Poly Radpicc | C.R. Bard, Inc. | 2003 | — |
| −6 | K033389 | Powerpicc Catheters, Models 3175155, 3175135 | C.R. Bard, Inc. | 2004 | 1 |
| −5 | K050185 | Powerhohn and Powerline Catheters | C.R. Bard, Inc. | 2005 | — |
| −4 | K051417 | 6 FR FL Powerhohn and Powerline Catheter | C.R. Bard, Inc. | 2005 | 1 |
| −3 | K051991 | Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power Line | C.R. Bard, Inc. | 2005 | — |
| −2 | K061179 | Powerhickman Long-Term Intravascular Catheter | C.R. Bard, Inc. | 2006 | — |
| −1 | K071538 | Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus Pressure Injectable Central Venous… | Arrow International, Inc. | 2007 | Class I |
| 0 (this device) | K190855 | BD Acute Central Line | Bard Access Systems, Inc. (Bard Has Joined Bd) | 2019 | — |
| +1 | K242429 | CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion… | Becton Dickinson Inc. (Bd) | 2025 | — |
| +1 | K221827 | Mais Central Venous Catheter | Saudi Mais Co. For Medical Products | 2023 | — |
| +1 | K200266 | BD Centro Vena Acute Central Line (7 French Dual Lumen) | Bard Access Systems, Inc. (Bard Has Joined Bd) | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1986 | 1 | 1 |
| 1989 | 1 | 0 |
| 1990 | 1 | 1 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 1 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 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.
4 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? (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 |
|---|---|---|---|
| * | K071538 | Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus Pressure Injectable Central Venous CatheterSummary page 4…21 CFR 880.5200 Premarket Notification #: K071538 Manufacturer: Arrow Classificati… | 2007 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (4 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.
- K071538Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus Pressure Injectable Central Venous CatheterArrow International, Inc. · 2007 · Direct predicate · ◆ on the line of descent in FIG. 15 Class I recalls
- K993691Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen Central Venous CatheterArrow Intl., Inc. · 2000 · 2 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
- K900263Antimicrobial Multi-Lumen Central Venous CatheterArrow Intl., Inc. · 1990 · 2 generations back · ◆ in the 1990 ancestors bar of FIG. 12 Class I recalls
- K862056[Central Venous][Multi-Lumen] Catheter W/Flex TipArrow Intl., Inc. · 1986 · 2 generations back · ◆ in the 1986 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 12 months on median.
- 13 of the 24 ancestors have a recall of any class; 4 have a Class I recall.
- Of its descendants, K242429 (Becton Dickinson Inc. (Bd), 2025) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K071538.
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. 2019, this device’s year, is highlighted.
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?
Acute central venous catheters are indicated to provide short-term access (<30 days) to the central venous system. They are designed for administering I.V. fluids, blood products, drugs and parenteral nutrition solutions, as well as blood withdrawal, central venous pressure monitoring, and power injection of contrast media.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190855 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190855: BD Acute Central Line.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190855
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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