510(k) · Cleared
ClearedSonoBlock; SonoBlock II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
PAJUNK GmbH Medizintechnologie · BSP Needle, Conduction, Anesthetic (W/Wo Introducer)
Cleared on Sep 11, 2024 as substantially equivalent to K111374 (PAJUNK GmbH Medizintechnologie, 2011) after a 70-day review. Its family tree reaches back 1 generation to 2011. 1 later device descends from it.
- Decided
- Sep 11, 2024
- Review
- 70 days
- Class
- Class II
- Product code
- BSP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K111374 (2011). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K243682SonoPlex STIM; SonoPlex IIPAJUNK GmbH Medizintechnologie · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K111374 | Sono-Series Cornerstone Technique | PAJUNK GmbH Medizintechnologie | 2011 | — |
| 0 (this device) | K241954 | SonoBlock; SonoBlock II | PAJUNK GmbH Medizintechnologie | 2024 | — |
| +1 | K243682 | SonoPlex STIM; SonoPlex II | PAJUNK GmbH Medizintechnologie | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 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 K243690 SonoMSKscore 10.5 · 4 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 |
|---|---|---|---|
| * | K111374 | Sono-Series Cornerstone TechniqueSummary page 7…*: 3009039068 Changes to Device: Predicate Device Device Name: SONO-SERIES CORNERSTONE TECHNIQUE Premarket Notification Number: K111374 Trade Name SonoPlex, SonoPlex STIM, SonoLong Classification Name: SonoPlex, Son… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243682 | SonoPlex STIM; SonoPlex II | 2025 | 0 |
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?
- Its one ancestor has no recall.
- Of its descendants, K243682 (PAJUNK GmbH Medizintechnologie, 2025) has gone furthest, with 0 descendants 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. 2024, this device’s year, is highlighted.
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) | — |
What is it indicated for?
SonoBlock and SonoBlock II Needles equipped with Cornerstone reflectors are used to puncture the tissue in order to gain
entry and inject local anaesthetics to induce regional anaesthesia.
Warning:
SonoBlock and SonoBlock II Needles are not intended for RF ablation or any other type of ablation procedure.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K241954 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241954: SonoBlock; SonoBlock II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241954
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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