510(k) · Cleared
ClearedAmbit Introducer, Ambit Needle, Ambit Sheath
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Summit Medical Products, Inc. · BSO Catheter, Conduction, Anesthetic
Cleared on Jan 13, 2011 as substantially equivalent to K063234 (I-Flow Corp., 2006) after a 139-day review. Its family tree reaches back 1 generation to 2006. 2 later devices descend from it.
- Decided
- Jan 13, 2011
- Review
- 139 days
- Class
- Class II
- Product code
- BSO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K063234 (2006). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK063234 ON-Q IntroducersI-Flow Corp. · 2006
- This deviceK102460 Ambit Introducer, Ambit Needle, Ambit SheathSummit Medical Products, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK200624 Percutaneous IntroducerEpimed International, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK171584 B. Braun Tear-Away Introducer NeedleB.Braun Medical, Inc. · 2017
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 | K063234 | ON-Q Introducers | I-Flow Corp. | 2006 | — |
| 0 (this device) | K102460 | Ambit Introducer, Ambit Needle, Ambit Sheath | Summit Medical Products, Inc. | 2011 | — |
| +1 | K200624 | Percutaneous Introducer | Epimed International, Inc. | 2020 | — |
| +1 | K171584 | B. Braun Tear-Away Introducer Needle | B.Braun Medical, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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.
Planning a device in BSO? 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 BSO device
- #1 K241410 EDEN ControlCathscore 9.5 · 3 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 |
|---|---|---|---|
| * | K063234 | ON-Q IntroducersSummary page 1…730 Regulation 868.5 120 Number: ______________________________________________ Eiquivalent K063 234 On-Q Introduceers pruaeu Device The amnbIT"' Introducer is intended f… | 2006 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All BSO devicesBSO Catheter, Conduction, Anesthetic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · BSO
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BSO
205in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BSO
2so far in 2026, the most since 2007
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · BSO
139in 2025
MAUDE reports naming product code BSO, 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 | 2 | — | 0 | 18 |
| 2008 | 3 | 155 | 0 | 14 |
| 2009 | 1 | — | 1 | 71 |
| 2010 | 1 | — | 0 | 57 |
| 2011 | 4 | 109 | 0 | 31 |
| 2012 | 0 | — | 0 | 52 |
| 2013 | 1 | — | 0 | 73 |
| 2014 | 2 | — | 0 | 45 |
| 2015 | 1 | — | 0 | 43 |
| 2016 | 5 | 281 | 0 | 71 |
| 2017 | 3 | 205 | 0 | 38 |
| 2018 | 2 | — | 0 | 80 |
| 2019 | 2 | — | 0 | 779 |
| 2020 | 2 | — | 0 | 159 |
| 2021 | 0 | — | 0 | 146 |
| 2022 | 0 | — | 0 | 135 |
| 2023 | 2 | — | 0 | 79 |
| 2024 | 0 | — | 0 | 98 |
| 2025 | 1 | — | 0 | 139 |
| 2026 | 0 | — | 2 (1) | — |
What is it indicated for?
The ambiT Introducer product line is intended to allow the percutaneous placement of catheters in close proximity to nerves and around or into surgical wound or non-surgical wound sites. It may be used to inject or aspirate the introduction area via the luer hub of the needle
The ambiT Introducer product line is intended for use by a physician or by a trained individual under direct supervision of a physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102460 · printed Nov 3, 2026
Cite this page
510(k) Report. “K102460: Ambit Introducer, Ambit Needle, Ambit Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K102460
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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