510(k) · Cleared
ClearedEmmebi Central Venous Catheter Kit with Lestep Safety Introducer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Emmebi Srl · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on Feb 4, 2005 as substantially equivalent to K963320 (Tfx Medical Group, 1996) and 1 other predicate after a 52-day review. Its family tree reaches back 2 generations to 1977.
- Decided
- Feb 4, 2005
- Review
- 52 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K770977 (1977). 22 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K770977 | Cardiovascular Spring Guides | Lake Region Mfg., Inc. | 1977 | 1 |
| −1 | K963320 | TFX Medical Guidewire | Tfx Medical Group | 1996 | — |
| 0 (this device) | K043446 | Emmebi Central Venous Catheter Kit with Lestep Safety Introducer | Emmebi Srl | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 2 | 0 |
| 1986 | 1 | 0 |
| 1987 | 3 | 0 |
| 1988 | 1 | 0 |
| 1990 | 4 | 0 |
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1997 | 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.
Planning a device in FOZ? 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? (6)
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 |
|---|---|---|---|
| * | K963320 | TFX Medical GuidewireSummary page 1…Catheter Predicate Device: Medcomp Quad Lumen Central Venous Catheter Predicate Guidewire: Lake Region K963320 Mfg., Inc. Predicate Introducer Raulerson K971281 - One Step Guidewire Syring… | 1996 |
| * | K971281 | Raulerson One-Step Guidewire Insertion Bulb NeedleSummary page 1…Catheter Predicate Guidewire: Lake Region K963320 Mfg., Inc. Predicate Introducer Raulerson K971281 - One Step Guidewire Syringe Insertion Bulb Needle Predicate Introducer Micro Stick… | 1997 |
| * | — | Arrowg+ard Blue Plus Multi-Lumen Central Venous Catheter Named without a submission number | |
| * | — | Triple Lumen Central Venous Catheter Named without a submission number | |
| * | — | Quad Lumen Central Venous Catheter Named without a submission number | |
| * | — | Micro Stick Introducer Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 3 companies; a new generation was cleared every 19.5 years on median.
- 3 of the 22 ancestors have a recall of any class.
- 3 other devices also cite its predicate K963320.
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?
The EmmeBi Lepstep Central Venous Catheter Kit is intended for short term use as an aid for catheterization of the superior vena cava for the purpose of performing parenteral infusional or nutritional therapy and to withdraw blood samples where the peripheral venous system is not practicable.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043446 · printed Nov 3, 2026
Cite this page
510(k) Report. “K043446: Emmebi Central Venous Catheter Kit with Lestep Safety Introducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K043446
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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