510(k) · Decided
DecidedEspocan Combined Spinal/Epidural Needle Set & Tray
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
B. Braun of America, Inc. · BSP Needle, Conduction, Anesthetic (W/Wo Introducer)
Cleared on Dec 13, 1993 after a 209-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Dec 13, 1993
- Review
- 209 days
- Class
- Class II
- Product code
- BSP
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK932400 Espocan Combined Spinal/Epidural Needle Set & TrayB. Braun of America, Inc. · 1993
- Descendant · cites it directly · 1 of its ownK060563 Epispin, Epispin II Safety, Epispin II, Epispin I, Epispin IVPajunk GmbH · 2006
- Descendant · 2 generations on · 0 of its ownK082183 Pajunk's Generic Convenience Tray for Regional Anesthesia: CSFPAJUNK GmbH Medizintechnologie · 2008
- Descendant · cites it directly · 0 of its ownK962880 Sensi-Touch Combo Spinal/Epidural Regional Anesthesia Delivery SystemSherwood Medical Co. · 1996
Most influential descendants
Showing 3 of 3 · See all- K060563Epispin, Epispin II Safety, Epispin II, Epispin I, Epispin IVPajunk GmbH · 2006 · cites it directly1descendant
- K082183Pajunk's Generic Convenience Tray for Regional Anesthesia: CSFPAJUNK GmbH Medizintechnologie · 2008 · 2 generations on0descendants
- K962880Sensi-Touch Combo Spinal/Epidural Regional Anesthesia Delivery SystemSherwood Medical Co. · 1996 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K932400 | Espocan Combined Spinal/Epidural Needle Set & Tray | B. Braun of America, Inc. | 1993 | — |
| +1 | K060563 | Epispin, Epispin II Safety, Epispin II, Epispin I, Epispin IV | Pajunk GmbH | 2006 | — |
| +2 | K082183 | Pajunk's Generic Convenience Tray for Regional Anesthesia: CSF | PAJUNK GmbH Medizintechnologie | 2008 | — |
| +1 | K962880 | Sensi-Touch Combo Spinal/Epidural Regional Anesthesia Delivery System | Sherwood Medical Co. | 1996 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in BSP? 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 BSP device
- #1 K241954 SonoBlock; SonoBlock IIscore 11.0 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
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?
- Of its descendants, K060563 (Pajunk GmbH, 2006) has gone furthest, with 1 descendant of its own.
How does its category compare?
All BSP devicesBSP Needle, Conduction, Anesthetic (W/Wo Introducer): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BSP
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BSP
170in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BSP
1in 2020
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · BSP
86in 2025
MAUDE reports naming product code BSP, 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 | 3 | 189 | 0 | 26 |
| 2008 | 8 | 127 | 0 | 24 |
| 2009 | 5 | 97 | 0 | 30 |
| 2010 | 3 | 79 | 0 | 49 |
| 2011 | 3 | 114 | 0 | 33 |
| 2012 | 3 | 148 | 0 | 20 |
| 2013 | 2 | — | 0 | 32 |
| 2014 | 2 | — | 0 | 41 |
| 2015 | 2 | — | 0 | 38 |
| 2016 | 6 | 268 | 1 | 152 |
| 2017 | 4 | 186 | 0 | 34 |
| 2018 | 8 | 241 | 0 | 69 |
| 2019 | 2 | — | 1 | 86 |
| 2020 | 3 | 269 | 1 | 78 |
| 2021 | 3 | 265 | 0 | 52 |
| 2022 | 2 | — | 0 | 84 |
| 2023 | 0 | — | 0 | 75 |
| 2024 | 3 | 70 | 0 | 66 |
| 2025 | 4 | 170 | 0 | 86 |
| 2026 | 0 | — | 1 (1) | — |
https://510kreport.com/device/K932400 · printed Nov 6, 2026
Cite this page
510(k) Report. “K932400: Espocan Combined Spinal/Epidural Needle Set & Tray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K932400
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026