510(k) · Cleared
ClearedSuprasson P Max
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Satelec · ELC Scaler, Ultrasonic
Cleared on Sep 29, 1995 after a 514-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 27 later devices descend from it.
- Decided
- Sep 29, 1995
- Review
- 514 days
- Class
- Class II
- Product code
- ELC
- Recalls
- None
- Predicates
- 0
27 later devices descend from it, 2 citing it directly.
- This deviceK942139 Suprasson P MaxSatelec · 1995
- Descendant · cites it directly · 26 of its ownK961158 Suprasson P5 BoosterSatelec · 1996
- Descendant · 2 generations on · 21 of its ownK972026 SP4044 & SP4055 Lux ModulesSatelec · 1997
- Descendant · 3 generations on · 20 of its ownK033764 SP Newtron ModuleSatelec · 2004
- Descendant · 2 generations on · 11 of its ownK050895 Surpasson P5 NewtronSatelec · 2005
- Descendant · 3 generations on · 4 of its ownK202906 EndoPilot2Schlumbohm GmbH & Co. KG · 2021
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K961158Suprasson P5 BoosterSatelec · 1996 · cites it directly26descendants
- K972026SP4044 & SP4055 Lux ModulesSatelec · 1997 · 2 generations on21descendants
- K033764SP Newtron ModuleSatelec · 2004 · 3 generations on20descendants
- K050895Surpasson P5 NewtronSatelec · 2005 · 2 generations on11descendants
- K202906EndoPilot2Schlumbohm GmbH & Co. KG · 2021 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K942139 | Suprasson P Max | Satelec | 1995 | — |
| +1 | K961158 | Suprasson P5 Booster | Satelec | 1996 | — |
| +2 | K972026 | SP4044 & SP4055 Lux Modules | Satelec | 1997 | — |
| +3 | K033764 | SP Newtron Module | Satelec | 2004 | — |
| +2 | K050895 | Surpasson P5 Newtron | Satelec | 2005 | — |
| +3 | K202906 | EndoPilot2 | Schlumbohm GmbH & Co. KG | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 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 ELC? 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 ELC device
- #1 K260773 Varios Combi Pro2score 12.5 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (27)
See all 272 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, K961158 (Satelec, 1996) has gone furthest, with 26 descendants of its own.
How does its category compare?
All ELC devicesELC Scaler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ELC
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ELC
104in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ELC
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ELC
284in 2025
MAUDE reports naming product code ELC, 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 | 6 | 92 | 0 | 12 |
| 2008 | 4 | 216 | 0 | 58 |
| 2009 | 4 | 121 | 0 | 108 |
| 2010 | 4 | 201 | 0 | 79 |
| 2011 | 3 | 122 | 0 | 5 |
| 2012 | 1 | — | 0 | 3 |
| 2013 | 13 | 174 | 0 | 6 |
| 2014 | 6 | 193 | 0 | 37 |
| 2015 | 5 | 150 | 0 | 135 |
| 2016 | 3 | 88 | 0 | 169 |
| 2017 | 2 | — | 0 | 356 |
| 2018 | 1 | — | 0 | 289 |
| 2019 | 4 | 192 | 0 | 302 |
| 2020 | 1 | — | 0 | 164 |
| 2021 | 3 | 196 | 0 | 166 |
| 2022 | 2 | — | 2 | 165 |
| 2023 | 5 | 258 | 0 | 210 |
| 2024 | 4 | 104 | 0 | 219 |
| 2025 | 2 | — | 0 | 284 |
| 2026 | 2 | — | 0 | — |
https://510kreport.com/device/K942139 · printed Nov 6, 2026
Cite this page
510(k) Report. “K942139: Suprasson P Max.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K942139
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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