510(k) · Cleared
ClearedACENT™ Central Venous Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Global Medikit Limited · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on Nov 24, 2020 as substantially equivalent to K070451 (Foshan Nanhai Bai HE Medical Technology Co., Ltd., 2007) after a 376-day review. Its family tree reaches back 3 generations to 1990. 2 of the 8 devices in its family, counting itself, have a Class I recall.
- Decided
- Nov 24, 2020
- Review
- 376 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K900263 (1990). 7 ancestors in all. No later device cites it as a predicate yet. 2 of the 8 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK900263 Antimicrobial Multi-Lumen Central Venous CatheterArrow Intl., Inc. · 1990 · Recalled (Class I)
- 2 generations backK021130 Specath Central Venous Catheter KitsSpecial Medical Co., Ltd. · 2003
- 1 generation backK070451 Able Central Venous CatheterFoshan Nanhai Bai HE Medical Technology Co., Ltd. · 2007
- This deviceK193158 ACENT™ Central Venous CatheterGlobal Medikit Limited · 2020
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K900263 | Antimicrobial Multi-Lumen Central Venous Catheter | Arrow Intl., Inc. | 1990 | Class I |
| −2 | K021130 | Specath Central Venous Catheter Kits | Special Medical Co., Ltd. | 2003 | — |
| −1 | K070451 | Able Central Venous Catheter | Foshan Nanhai Bai HE Medical Technology Co., Ltd. | 2007 | — |
| 0 (this device) | K193158 | ACENT™ Central Venous Catheter | Global Medikit Limited | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 2000 | 1 | 1 |
| 2003 | 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.
2 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 |
|---|---|---|---|
| * | K070451 | Able Central Venous CatheterSummary page 4…Name : Able Central Venous Catheter Manufacture : Foshan Nanhai Bai He Medical Technology Co., Ltd 510(K) No. : K070451 IV. Device Description ACENTTM catheters are polyurethane, radiopaque single, double, or triple lumen catheters. The ca… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 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.
- K993691Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen Central Venous CatheterArrow Intl., Inc. · 2000 · 3 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
- K900263Antimicrobial Multi-Lumen Central Venous CatheterArrow Intl., Inc. · 1990 · 3 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 30 years and passes through 4 companies; a new generation was cleared every 12.5 years on median.
- 4 of the 7 ancestors have a recall of any class; 2 have a Class I recall.
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. 2020, 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?
ACENT™ Central Venous Catheter is an intravascular catheter, designed for infusion of fluid to the central venous system and/or for pressure measurements.
- for short-term (less than 30 days) infusion therapy or parenteral nutrition
- for continuous or intermittent monitoring of the central venous pressure,
- for blood sampling.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193158 · printed Nov 4, 2026
Cite this page
510(k) Report. “K193158: ACENT™ Central Venous Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K193158
Report an extraction error
Are you the manufacturer?
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