510(k) · Cleared
ClearedAir Flow Sii
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 Apr 18, 1990 after a 139-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
- Apr 18, 1990
- Review
- 139 days
- Class
- Class II
- Product code
- ELC
- Recalls
- None
- Predicates
- 0
32 later devices descend from it, 4 citing it directly.
- This deviceK900709 Air Flow SiiElectro Medical Systems (Ems Sa) · 1990
- Descendant · cites it directly · 25 of its ownK073284 Air-Flow Master Standard(Ems Sa) Electro Medical Systems · 2007
- Descendant · 2 generations on · 23 of its ownK082791 Ems Air-Flow MasterE.M.S Electro Medical Systems S.A · 2009
- Descendant · cites it directly · 23 of its ownK991857 Airflow HandyElectro Medical Systems, Inc. · 1999
- Descendant · 2 generations on · 22 of its ownK022119 Ems Air-Flow Handy 2 Dental HandpieceElectro Medical Systems SA · 2002
- Descendant · 3 generations on · 18 of its ownK092289 Ems Air-Flow Handy PerioE.M.S Electro Medical Systems S.A · 2009
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 32 · See all- K073284Air-Flow Master Standard(Ems Sa) Electro Medical Systems · 2007 · cites it directly25descendants
- K082791Ems Air-Flow MasterE.M.S Electro Medical Systems S.A · 2009 · 2 generations on23descendants
- K991857Airflow HandyElectro Medical Systems, Inc. · 1999 · cites it directly23descendants
- K022119Ems Air-Flow Handy 2 Dental HandpieceElectro Medical Systems SA · 2002 · 2 generations on22descendants
- K092289Ems Air-Flow Handy PerioE.M.S Electro Medical Systems S.A · 2009 · 3 generations on18descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K900709 | Air Flow Sii | Electro Medical Systems (Ems Sa) | 1990 | — |
| +1 | K073284 | Air-Flow Master Standard | (Ems Sa) Electro Medical Systems | 2007 | — |
| +2 | K082791 | Ems Air-Flow Master | E.M.S Electro Medical Systems S.A | 2009 | — |
| +1 | K991857 | Airflow Handy | Electro Medical Systems, Inc. | 1999 | — |
| +2 | K022119 | Ems Air-Flow Handy 2 Dental Handpiece | Electro Medical Systems SA | 2002 | — |
| +3 | K092289 | Ems Air-Flow Handy Perio | E.M.S Electro Medical Systems S.A | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 3 | 0 |
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 4 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 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 324 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, K073284 ((Ems Sa) Electro Medical Systems, 2007) has gone furthest, with 25 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/K900709 · printed Nov 6, 2026
Cite this page
510(k) Report. “K900709: Air Flow Sii.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K900709
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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