510(k) · Cleared
ClearedElectro Flo 6 Airway Clearance System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Med Systems, Inc. · BYI Percussor, Powered-Electric
Cleared on Feb 12, 2021 as substantially equivalent to K173603 (Hill-Rom Holdings, Inc., 2018) and 1 other predicate after a 253-day review. Its family tree reaches back 8 generations to 1988.
- Decided
- Feb 12, 2021
- Review
- 253 days
- Class
- Class II
- Product code
- BYI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K884098 (1988). 14 ancestors in all, the oldest K801982 (1980). No later device cites it as a predicate yet.
- Root · 8 generations backK884098 Thairapy (TM) Bronchial Drainage System, Model 101American Biosystems, Inc. · 1988
- 7 generations backK965192 Thairapy Vest SystemAmerican Biosystems, Inc. · 1997
- 6 generations backK993629 Abi Vest Airway Clearance SystemAmerican Biosystems, Inc. · 2000
- 5 generations backK012928 Abi Vest Airway Clearance SystemAdvanced Respiratory · 2001
- 4 generations backK024309 The Vest Airway Clearance System, Model 104Advanced Respiratory · 2003
- 3 generations backK142482 The Vest Airway Clearance SystemHill-Rom Services Private Limited · 2015
- 2 generations backK163378 Monarch Airway Clearance SystemHill-Rom Services Pte, Ltd. · 2017 · Recalled
- 1 generation backK173603 Monarch Airway Clearance SystemHill-Rom Holdings, Inc. · 2018
- This deviceK201490 Electro Flo 6 Airway Clearance SystemMed Systems, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K884098 | Thairapy (TM) Bronchial Drainage System, Model 101 | American Biosystems, Inc. | 1988 | — |
| −7 | K965192 | Thairapy Vest System | American Biosystems, Inc. | 1997 | — |
| −6 | K993629 | Abi Vest Airway Clearance System | American Biosystems, Inc. | 2000 | — |
| −5 | K012928 | Abi Vest Airway Clearance System | Advanced Respiratory | 2001 | — |
| −4 | K024309 | The Vest Airway Clearance System, Model 104 | Advanced Respiratory | 2003 | — |
| −3 | K142482 | The Vest Airway Clearance System | Hill-Rom Services Private Limited | 2015 | — |
| −2 | K163378 | Monarch Airway Clearance System | Hill-Rom Services Pte, Ltd. | 2017 | 1 |
| −1 | K173603 | Monarch Airway Clearance System | Hill-Rom Holdings, Inc. | 2018 | — |
| 0 (this device) | K201490 | Electro Flo 6 Airway Clearance System | Med Systems, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 2 | 0 |
| 1981 | 1 | 0 |
| 1982 | 2 | 0 |
| 2003 | 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 BYI? 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 BYI device
- #1 K252849 AffloVest® Mobile Airway Clearance Therapyscore 12.5 · 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 |
|---|---|---|---|
| * | K173603 | Monarch Airway Clearance SystemSummary page 4…CFR 868.5665, “Powered Percussor” Class II III. PREDICATE DEVICES Primary Predicate: Monarch Airway Clearance System (K173603) Classification Code: BYI, “Percussor, Powered-Electric” Regulation 2… | 2018 |
| * | K031876 | Electro Flo Percussor, Model 5000Summary page 4…“Powered Percussor” Class II Reference Predicate: Med Systems Electro Flo Percussor Model 5000 (K031876) Classification Code: BYI, “Percussor, Powered-Electric” Regulati… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
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 33 years and passes through 6 companies; a new generation was cleared every 2.3 years on median.
- 1 of the 14 ancestors has a recall of any class.
How does its category compare?
All BYI devicesBYI Percussor, Powered-Electric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · BYI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BYI
157in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BYI
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · BYI
38in 2025
MAUDE reports naming product code BYI, 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 | 1 | — | 0 | 8 |
| 2008 | 0 | — | 0 | 5 |
| 2009 | 0 | — | 0 | 8 |
| 2010 | 1 | — | 0 | 7 |
| 2011 | 1 | — | 0 | 17 |
| 2012 | 1 | — | 0 | 8 |
| 2013 | 3 | 225 | 0 | 6 |
| 2014 | 0 | — | 1 | 10 |
| 2015 | 1 | — | 0 | 4 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 1 | — | 1 | 4 |
| 2018 | 1 | — | 0 | 9 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 4 |
| 2021 | 2 | — | 0 | 15 |
| 2022 | 1 | — | 0 | 16 |
| 2023 | 0 | — | 0 | 9 |
| 2024 | 3 | 157 | 0 | 19 |
| 2025 | 1 | — | 0 | 38 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Electro Flo® 6 Airway Clearance System is intended to provide Airway Clearance Therapy and promote bronchial drainage where external manipulation of the thorax is the physician's choice of treatment. It is indicated for patients having difficulty with secretion clearance, or the presence of atelectasis caused by mucus plugging.
The device is intended for home or institutional use by patients weighing at least 23 Kg.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201490 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201490: Electro Flo 6 Airway Clearance System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201490
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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