510(k) · Cleared
ClearedPercutaneous Introducer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Epimed International, Inc. · BSO Catheter, Conduction, Anesthetic
Cleared on Apr 27, 2020 as substantially equivalent to K102460 (Summit Medical Products, Inc., 2011) and 1 other predicate after a 48-day review. Its family tree reaches back 2 generations to 1993.
- Decided
- Apr 27, 2020
- Review
- 48 days
- Class
- Class II
- Product code
- BSO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K904380 (1993). 4 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 | K904380 | Spinal Cord Access Epidural Introducer System | Custom Medical Concepts, Inc. | 1993 | — |
| −1 | K051860 | Flexible Introducer Cannula, Model 135-1837 | Epimed International, Inc. | 2005 | — |
| 0 (this device) | K200624 | Percutaneous Introducer | Epimed International, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2011 | 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? (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 |
|---|---|---|---|
| * | K102460 | Ambit Introducer, Ambit Needle, Ambit SheathSummary page 4…Catheter, BSO (21 CFR 868.5120) Classification: Class II Predicate Device Information: Predicate device ambit Introducer (K102460) Reference Device Information: Flexible Introducer Cannula (K051860) Device Description: The Percutaneous Introd… | 2011 |
| * | K051860 | Flexible Introducer Cannula, Model 135-1837Summary page 4…ification: Class II Predicate Device Information: Predicate device ambit Introducer (K102460) Reference Device Information: Flexible Introducer Cannula (K051860) Device Description: The Percutaneous Introducer is a single-use, disposable device consisting of a flexible pol… | 2005 |
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 27 years and passes through 2 companies; a new generation was cleared every 14.7 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K102460.
How does its category compare?
All BSO devicesBSO Catheter, Conduction, Anesthetic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 Percutaneous Introducer is intended to allow for the percutaneous placement of devices, such as catheters, needles or probes, 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/introducer.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200624 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200624: Percutaneous Introducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200624
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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