510(k) · Cleared
ClearedON-Q Introducers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
I-Flow Corp. · BSO Catheter, Conduction, Anesthetic
Cleared on Nov 21, 2006 after a 27-day review. The FDA summary names no predicate by number. 5 later devices descend from it.
- Decided
- Nov 21, 2006
- Review
- 27 days
- Class
- Class II
- Product code
- BSO
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK063234 ON-Q IntroducersI-Flow Corp. · 2006
- Descendant · cites it directly · 2 of its ownK102460 Ambit Introducer, Ambit Needle, Ambit SheathSummit Medical Products, Inc. · 2011
- Descendant · 2 generations on · 0 of its ownK200624 Percutaneous IntroducerEpimed International, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK171584 B. Braun Tear-Away Introducer NeedleB.Braun Medical, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK110814 Ambit TunnelerSummit Medical Products, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK102594 IO-Flex CatheterBaxano, Inc. · 2011
Most influential descendants
Showing 5 of 5 · See all- K102460Ambit Introducer, Ambit Needle, Ambit SheathSummit Medical Products, Inc. · 2011 · cites it directly2descendants
- K200624Percutaneous IntroducerEpimed International, Inc. · 2020 · 2 generations on0descendants
- K171584B. Braun Tear-Away Introducer NeedleB.Braun Medical, Inc. · 2017 · 2 generations on0descendants
- K110814Ambit TunnelerSummit Medical Products, Inc. · 2011 · cites it directly0descendants
- K102594IO-Flex CatheterBaxano, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K063234 | ON-Q Introducers | I-Flow Corp. | 2006 | — |
| +1 | K102460 | Ambit Introducer, Ambit Needle, Ambit Sheath | Summit Medical Products, Inc. | 2011 | — |
| +2 | K200624 | Percutaneous Introducer | Epimed International, Inc. | 2020 | — |
| +2 | K171584 | B. Braun Tear-Away Introducer Needle | B.Braun Medical, Inc. | 2017 | — |
| +1 | K110814 | Ambit Tunneler | Summit Medical Products, Inc. | 2011 | — |
| +1 | K102594 | IO-Flex Catheter | Baxano, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 3 | 0 |
| 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 9.4 · 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?
The FDA summary names no predicate by number.
What descends from it? (5)
3 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?
- Of its descendants, K102460 (Summit Medical Products, Inc., 2011) has gone furthest, with 2 descendants of its own.
How does its category compare?
All BSO devicesBSO Catheter, Conduction, Anesthetic: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 ON-Q Introducers are intended for the percutaneous introduction and placement of catheters into or around surgical wound sites and/or close proximity to nerves. Introducers with a luer hub may be used to aspirate or inject a bolus of fluid or medication prior to placing the catheters.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063234 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063234: ON-Q Introducers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063234
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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