510(k) · Cleared
ClearedAble Central Venous Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Foshan Nanhai Bai HE Medical Technology Co., Ltd. · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on Jul 31, 2007 as substantially equivalent to K021130 (Special Medical Co., Ltd., 2003) and 1 other predicate after a 166-day review. Its family tree reaches back 2 generations to 1990. 2 of the 8 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- Jul 31, 2007
- Review
- 166 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K900263 (1990). 6 ancestors in all. 1 later device descends from it, 1 citing it directly. 2 of the 8 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK900263 Antimicrobial Multi-Lumen Central Venous CatheterArrow Intl., Inc. · 1990 · Recalled (Class I)
- 1 generation backK021130 Specath Central Venous Catheter KitsSpecial Medical Co., Ltd. · 2003
- This deviceK070451 Able Central Venous CatheterFoshan Nanhai Bai HE Medical Technology Co., Ltd. · 2007
- Descendant · cites it directly · 0 of its ownK193158 ACENT™ Central Venous CatheterGlobal Medikit Limited · 2020
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K193158ACENT™ Central Venous CatheterGlobal Medikit Limited · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K900263 | Antimicrobial Multi-Lumen Central Venous Catheter | Arrow Intl., Inc. | 1990 | Class I |
| −1 | K021130 | Specath Central Venous Catheter Kits | Special Medical Co., Ltd. | 2003 | — |
| 0 (this device) | K070451 | Able Central Venous Catheter | Foshan Nanhai Bai HE Medical Technology Co., Ltd. | 2007 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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? (2)
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 |
|---|---|---|---|
| * | K021130 | Specath Central Venous Catheter KitsSummary page 2…809 Email: Diana.hong~mid-link.net 3. Predicate Device a) Predicate device for single-lumen and double-lumen SPECATHB Central Venous Catheter Kits (K021130) Manufactured by: Special Medical Co. Ltd No. 3 Industrial Building, National Hi-Tech Development Zone G… | 2003 |
| * | K024007 | Sunder Central Venous Catheter Kit, Models SD-3L55F30J and SD-3L70F30JSummary page 2…nal Hi-Tech Development Zone GangKou Road Guangdong 528041, China b) Predicate device for triple-lumen Sunder Central Venous Catheter Kit (K024007) Manufactured by: Sunder Biomedical Tech. Co., Ltd I OF- 1. 1-67, Wu-Chuan Rd., Taichuns. Taiwan 403 Chi… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K193158 | ACENT™ Central Venous Catheter | 2020 | 0 |
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 · 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 · ◆ on the line of descent in FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 12.5 years on median.
- 4 of the 6 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K193158 (Global Medikit Limited, 2020) has gone furthest, with 0 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. 2007, 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?
The Central Venous Catheters including:
14 G. 16 G. 18 C, and 20 G in single-lumen catheters;
4 F.5 F, 7 F and 8 F in double-lumen catheter;
5.5 F and 7 F in triple-lumen catheter;
are intended for vascular access infusion and withdrawal of blood, blood products, and fluids, plasma pheresis, hyperalimentation, central venous blood sampling and continuous and intermittent drag infusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070451 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070451: Able Central Venous Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070451
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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