510(k) · Cleared
ClearedAir-Flow Handy 3.0 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 Feb 24, 2014 as substantially equivalent to K082791 (E.M.S Electro Medical Systems S.A, 2009) after a 200-day review. Its family tree reaches back 3 generations to 1990. 4 later devices descend from it.
- Decided
- Feb 24, 2014
- Review
- 200 days
- Class
- Class I
- Product code
- EFB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K900709 (1990). 4 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK900709 Air Flow SiiElectro Medical Systems (Ems Sa) · 1990
- 2 generations backK073284 Air-Flow Master Standard(Ems Sa) Electro Medical Systems · 2007
- 1 generation backK082791 Ems Air-Flow MasterE.M.S Electro Medical Systems S.A · 2009
- This deviceK132480 Air-Flow Handy 3.0 PerioE.M.S Electro Medical Systems S.A · 2014
- Descendant · cites it directly · 2 of its ownK151912 AIR-FLOW handy 3.0 PLUSE.M.S Electro Medical Systems S.A · 2016
- Descendant · cites it directly · 1 of its ownK171174 PERIO-FLOW nozzleE.M.S Electro Medical Systems S.A · 2017
- Descendant · 2 generations on · 0 of its ownK241880 Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth…Nakanishi, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK221548 Dental Air Polishing HandpieceGuilin Woodpecker Medical Instrument Co., Ltd. · 2022
Most influential descendants
Showing 4 of 4 · See all- K151912AIR-FLOW handy 3.0 PLUSE.M.S Electro Medical Systems S.A · 2016 · cites it directly2descendants
- K171174PERIO-FLOW nozzleE.M.S Electro Medical Systems S.A · 2017 · cites it directly1descendant
- K241880Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System…Nakanishi, Inc. · 2024 · 2 generations on0descendants
- K221548Dental Air Polishing HandpieceGuilin Woodpecker Medical Instrument Co., Ltd. · 2022 · 2 generations on0descendants
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 | K073284 | Air-Flow Master Standard | (Ems Sa) Electro Medical Systems | 2007 | — |
| −1 | K082791 | Ems Air-Flow Master | E.M.S Electro Medical Systems S.A | 2009 | — |
| 0 (this device) | K132480 | Air-Flow Handy 3.0 Perio | E.M.S Electro Medical Systems S.A | 2014 | — |
| +1 | K151912 | AIR-FLOW handy 3.0 PLUS | E.M.S Electro Medical Systems S.A | 2016 | — |
| +1 | K171174 | PERIO-FLOW nozzle | E.M.S Electro Medical Systems S.A | 2017 | — |
| +2 | K241880 | Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing… | Nakanishi, Inc. | 2024 | — |
| +2 | K221548 | Dental Air Polishing Handpiece | Guilin Woodpecker Medical Instrument Co., Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 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 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? (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 |
|---|---|---|---|
| * | K082791 | Ems Air-Flow MasterSummary page 1…handpiece Classification Name: Dental handpiece and accessories 3. PREDICATE DEVICE *E.MS. ELECTRO MEDICAL SYSTEMS S.A., AIR-FLOW handy PERIO (K08279 1) 4. DEVICE DESCRIPTION The proposed AIR-FLOW handy 3.0 PERIO is a modification of the AIR-FLOW handy PERIO Dental l-an… | 2009 |
What descends from it? (4)
2 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 24 years and passes through 3 companies; a new generation was cleared every 5.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K151912 (E.M.S Electro Medical Systems S.A, 2016) has gone furthest, with 2 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. 2014, 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 AmR-FLOW handy 3.0 PERIO is intended far patients suffering from periodontal disease.
The AmR-FLOW handy 3.0 PERIO is indicated for the non-surgical removal of subgingival plaque in packets up to 5 mm after initial periodontal treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132480 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132480: Air-Flow Handy 3.0 Perio.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132480
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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