510(k) · Cleared
ClearedEms Air-Flow Handy Perio
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
E.M.S Electro Medical Systems S.A · EFB Handpiece, Air-Powered, Dental
Cleared on Oct 20, 2009 as substantially equivalent to K082791 (E.M.S Electro Medical Systems S.A, 2009) and 1 other predicate after an 83-day review. Its family tree reaches back 3 generations to 1990. 18 later devices descend from it.
- Decided
- Oct 20, 2009
- Review
- 83 days
- Class
- Class I
- Product code
- EFB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K900709 (1990). 6 ancestors in all. 18 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK900709 Air Flow SiiElectro Medical Systems (Ems Sa) · 1990
- 2 generations backK991857 Airflow HandyElectro Medical Systems, Inc. · 1999
- 1 generation backK022119 Ems Air-Flow Handy 2 Dental HandpieceElectro Medical Systems SA · 2002
- This deviceK092289 Ems Air-Flow Handy PerioE.M.S Electro Medical Systems S.A · 2009
- Descendant · cites it directly · 13 of its ownK110173 Ems Air-Flow Master PiezonE.M.S Electro Medical Systems S.A · 2011
- Descendant · 2 generations on · 4 of its ownK190124 EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW OneE.M.S Electro Medical Systems S.A · 2019 · Recalled
- Descendant · 2 generations on · 3 of its ownK132478 Air-Flow Handy 3.0E.M.S Electro Medical Systems S.A · 2014
- Descendant · cites it directly · 3 of its ownK110379 Air-N-GOSatelec · 2011
- Descendant · 3 generations on · 2 of its ownK151912 AIR-FLOW handy 3.0 PLUSE.M.S Electro Medical Systems S.A · 2016
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K110173Ems Air-Flow Master PiezonE.M.S Electro Medical Systems S.A · 2011 · cites it directly13descendants
- K190124EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW OneE.M.S Electro Medical Systems S.A · 2019 · 2 generations on4descendants
- K132478Air-Flow Handy 3.0E.M.S Electro Medical Systems S.A · 2014 · 2 generations on3descendants
- K110379Air-N-GOSatelec · 2011 · cites it directly3descendants
- K151912AIR-FLOW handy 3.0 PLUSE.M.S Electro Medical Systems S.A · 2016 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K900709 | Air Flow Sii | Electro Medical Systems (Ems Sa) | 1990 | — |
| −2 | K991857 | Airflow Handy | Electro Medical Systems, Inc. | 1999 | — |
| −1 | K022119 | Ems Air-Flow Handy 2 Dental Handpiece | Electro Medical Systems SA | 2002 | — |
| 0 (this device) | K092289 | Ems Air-Flow Handy Perio | E.M.S Electro Medical Systems S.A | 2009 | — |
| +1 | K110173 | Ems Air-Flow Master Piezon | E.M.S Electro Medical Systems S.A | 2011 | — |
| +2 | K190124 | EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One | E.M.S Electro Medical Systems S.A | 2019 | 3 |
| +2 | K132478 | Air-Flow Handy 3.0 | E.M.S Electro Medical Systems S.A | 2014 | — |
| +1 | K110379 | Air-N-GO | Satelec | 2011 | — |
| +3 | K151912 | AIR-FLOW handy 3.0 PLUS | E.M.S Electro Medical Systems S.A | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 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), 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 EFB? 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 EFB device
- #1 K262144 DIAMED Handpiece;DIAMED Airmotor;DIAMED…score 13.3 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K082791 | Ems Air-Flow MasterSummary page 1…Dental handpiece Classification Name: Dental handpiece and accessories 3. PREDICATE DEVICES * Electro Medical Systems S.A., ATR-FLOW MASTER (K082791) * Electro Medical Systems S.A., AIR-FLOW handy 2 (K022119) 4. INTENDED USE The EMS AIR-FLOW handy PERIO is inte… | 2009 |
| * | K022119 | Ems Air-Flow Handy 2 Dental HandpieceSummary page 1…iece and accessories 3. PREDICATE DEVICES * Electro Medical Systems S.A., ATR-FLOW MASTER (K082791) * Electro Medical Systems S.A., AIR-FLOW handy 2 (K022119) 4. INTENDED USE The EMS AIR-FLOW handy PERIO is intended for patients suffering from periodontal disease. Th… | 2002 |
What descends from it? (18)
See all 184 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?
- The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 7.2 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K110173 (E.M.S Electro Medical Systems S.A, 2011) has gone furthest, with 13 descendants of its own.
- 5 other devices also cite its predicate K082791.
How does its category compare?
All EFB devicesEFB Handpiece, Air-Powered, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · EFB
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EFB
209in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EFB
No recall names EFB since 2007.
Adverse event reports per year · EFB
83in 2025
MAUDE reports naming product code EFB, 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 | 12 | 61 | 0 | 13 |
| 2008 | 7 | 97 | 0 | 19 |
| 2009 | 11 | 120 | 0 | 40 |
| 2010 | 8 | 116 | 0 | 78 |
| 2011 | 4 | 168 | 0 | 96 |
| 2012 | 8 | 130 | 0 | 97 |
| 2013 | 3 | 207 | 0 | 61 |
| 2014 | 7 | 200 | 0 | 73 |
| 2015 | 7 | 296 | 0 | 87 |
| 2016 | 3 | 205 | 0 | 122 |
| 2017 | 7 | 246 | 0 | 153 |
| 2018 | 3 | 210 | 0 | 81 |
| 2019 | 3 | 348 | 0 | 117 |
| 2020 | 5 | 259 | 0 | 94 |
| 2021 | 2 | — | 0 | 123 |
| 2022 | 5 | 430 | 0 | 157 |
| 2023 | 4 | 158 | 0 | 116 |
| 2024 | 5 | 209 | 0 | 104 |
| 2025 | 1 | — | 0 | 83 |
| 2026 | 4 | 252 | 0 | — |
What is it indicated for?
The EMS AIR-FLOW handy PERIO is intended for patients suffering from periodontal disease.
The EMS AIR-FLOW handy PERIO is indicated for the non-surgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092289 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092289: Ems Air-Flow Handy Perio.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092289
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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