510(k) · Cleared
ClearedPiezon Master 400
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Electro Medical Systems (Ems Sa) · ELC Scaler, Ultrasonic
Cleared on Aug 31, 1990 after a 274-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 32 later devices descend from it.
- Decided
- Aug 31, 1990
- Review
- 274 days
- Class
- Class II
- Product code
- ELC
- Recalls
- None
- Predicates
- 0
32 later devices descend from it, 3 citing it directly.
- This deviceK896749 Piezon Master 400Electro Medical Systems (Ems Sa) · 1990
- Descendant · cites it directly · 30 of its ownK992504 Ems Kermit(Ems Sa) Electro Medical Systems · 2000
- Descendant · 2 generations on · 17 of its ownK050710 Minimaster Ultrasonic ScalerE.M.S Electro Medical Systems S.A · 2005
- Descendant · 3 generations on · 14 of its ownK093723 Ems Minimaster LedE.M.S Electro Medical Systems S.A · 2010
- Descendant · 4 generations on · 13 of its ownK110173 Ems Air-Flow Master PiezonE.M.S Electro Medical Systems S.A · 2011
- Descendant · cites it directly · 12 of its ownK022328 Ems Piezon Master 600Electro Medical Systems SA · 2002
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 32 · See all- K992504Ems Kermit(Ems Sa) Electro Medical Systems · 2000 · cites it directly30descendants
- K050710Minimaster Ultrasonic ScalerE.M.S Electro Medical Systems S.A · 2005 · 2 generations on17descendants
- K093723Ems Minimaster LedE.M.S Electro Medical Systems S.A · 2010 · 3 generations on14descendants
- K110173Ems Air-Flow Master PiezonE.M.S Electro Medical Systems S.A · 2011 · 4 generations on13descendants
- K022328Ems Piezon Master 600Electro Medical Systems SA · 2002 · cites it directly12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K896749 | Piezon Master 400 | Electro Medical Systems (Ems Sa) | 1990 | — |
| +1 | K992504 | Ems Kermit | (Ems Sa) Electro Medical Systems | 2000 | — |
| +2 | K050710 | Minimaster Ultrasonic Scaler | E.M.S Electro Medical Systems S.A | 2005 | — |
| +3 | K093723 | Ems Minimaster Led | E.M.S Electro Medical Systems S.A | 2010 | — |
| +4 | K110173 | Ems Air-Flow Master Piezon | E.M.S Electro Medical Systems S.A | 2011 | — |
| +1 | K022328 | Ems Piezon Master 600 | Electro Medical Systems SA | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (32)
See all 323 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, K992504 ((Ems Sa) Electro Medical Systems, 2000) has gone furthest, with 30 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/K896749 · printed Nov 4, 2026
Cite this page
510(k) Report. “K896749: Piezon Master 400.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K896749
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026