510(k) · Cleared
ClearedSpecath Central Venous Catheter Kits
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Special Medical Co., Ltd. · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on Jan 7, 2003 as substantially equivalent to K963257 (Arrow Intl., Inc., 1997) and 2 other predicates after a 273-day review. Its family tree reaches back 1 generation to 1990. 1 of the 6 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.
- Decided
- Jan 7, 2003
- Review
- 273 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K900263 (1990). 3 ancestors in all. 2 later devices descend from it, 1 citing it directly. 1 of the 6 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK900263 Antimicrobial Multi-Lumen Central Venous CatheterArrow Intl., Inc. · 1990 · Recalled (Class I)
- This deviceK021130 Specath Central Venous Catheter KitsSpecial Medical Co., Ltd. · 2003
- Descendant · cites it directly · 1 of its ownK070451 Able Central Venous CatheterFoshan Nanhai Bai HE Medical Technology Co., Ltd. · 2007
- Descendant · 2 generations on · 0 of its ownK193158 ACENT™ Central Venous CatheterGlobal Medikit Limited · 2020
Class I recalls in this family
- K900263 Antimicrobial Multi-Lumen Central Venous Catheterdirect predicate · 1990
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K900263 | Antimicrobial Multi-Lumen Central Venous Catheter | Arrow Intl., Inc. | 1990 | Class I |
| 0 (this device) | 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 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 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.
1 device in this family has 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? (3)
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 |
|---|---|---|---|
| * | K963257 | Peripherally Inserted Medline CatheterSummary page 1…Date Summary Prepared: April 5, 2002 2. Name of the Device: SPECATHB Central Venous Catheter Kits 3. Predicate Device Information: 1. K#963257, Peripherally Inserted Medline Catheter, Arrow International, Inc. 2. K#900263 Anti-Microbial Multi-Lumen Central Venous C… | 1997 |
| * | K900263 | Antimicrobial Multi-Lumen Central Venous CatheterSummary page 1…THB Central Venous Catheter Kits 3. Predicate Device Information: 1. K#963257, Peripherally Inserted Medline Catheter, Arrow International, Inc. 2. K#900263 Anti-Microbial Multi-Lumen Central Venous Catheter, Arrow International, Inc. 3. K#971085, Soft Tip Multi-Lumen… | 1990 |
| * | K971085 | Soft Tip Multi-Lumen Central Venous CatheterSummary page 1…serted Medline Catheter, Arrow International, Inc. 2. K#900263 Anti-Microbial Multi-Lumen Central Venous Catheter, Arrow International, Inc. 3. K#971085, Soft Tip Multi-Lumen Central Venous Catheter, B. Braun Medical, Inc. 4. Device Description: SPECATH@cathe… | 1997 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070451 | Able Central Venous Catheter | 2007 | 1 |
Has anything in its family been recalled? (1 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.
- K900263Antimicrobial Multi-Lumen Central Venous CatheterArrow Intl., Inc. · 1990 · Direct predicate · ◆ on the line of descent in FIG. 12 Class I recalls
What does this lineage say?
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?
SPECATHB Central Venous Catheters are intended for the purpose cf providing short term access (less than 30 days) to the vascular system for the infusion of fluids, monitoring of pressures, and/or sampling of blood.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021130 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021130: Specath Central Venous Catheter Kits.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021130
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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