510(k) · Cleared
ClearedElectro Flo Percussor, Model 5000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Med Systems · BYI Percussor, Powered-Electric
Cleared on Nov 21, 2003 as substantially equivalent to K802399 (Medical Equipment Development Co., Inc., 1980) and 4 other predicates after a 157-day review. Its family tree reaches back 1 generation to 1980. 5 later devices descend from it.
- Decided
- Nov 21, 2003
- Review
- 157 days
- Class
- Class II
- Product code
- BYI
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 1 generation to K801982 (1980). 5 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK801982 The Mcshirley PercussorMcshirley Products, Inc. · 1980
- This deviceK031876 Electro Flo Percussor, Model 5000Med Systems · 2003
- Descendant · cites it directly · 3 of its ownK063645 Frequencer, Model 1001Dymedso, Inc. · 2007
- Descendant · 2 generations on · 2 of its ownK100749 Frequencer Model V2XDymedso, Inc. · 2010
- Descendant · 3 generations on · 1 of its ownK103176 FrequencerDymedso, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK201490 Electro Flo 6 Airway Clearance SystemMed Systems, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK133057 Vibralung Acoustical PercussorWestmed, Inc. · 2014
Most influential descendants
Showing 5 of 5 · See all- K063645Frequencer, Model 1001Dymedso, Inc. · 2007 · cites it directly3descendants
- K100749Frequencer Model V2XDymedso, Inc. · 2010 · 2 generations on2descendants
- K103176FrequencerDymedso, Inc. · 2011 · 3 generations on1descendant
- K201490Electro Flo 6 Airway Clearance SystemMed Systems, Inc. · 2021 · cites it directly0descendants
- K133057Vibralung Acoustical PercussorWestmed, Inc. · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K801982 | The Mcshirley Percussor | Mcshirley Products, Inc. | 1980 | — |
| 0 (this device) | K031876 | Electro Flo Percussor, Model 5000 | Med Systems | 2003 | — |
| +1 | K063645 | Frequencer, Model 1001 | Dymedso, Inc. | 2007 | — |
| +2 | K100749 | Frequencer Model V2X | Dymedso, Inc. | 2010 | — |
| +3 | K103176 | Frequencer | Dymedso, Inc. | 2011 | — |
| +1 | K201490 | Electro Flo 6 Airway Clearance System | Med Systems, Inc. | 2021 | — |
| +2 | K133057 | Vibralung Acoustical Percussor | Westmed, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1981 | 1 | 0 |
| 1982 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2021 | 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? (5)
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 |
|---|---|---|---|
| * | K802399 | Model 2500 Pneumatic PercussorSummary page 1…ces: This product is similar in function to the Model 2500 “Fluid Flo” percussor that our company has manufactured for hospitals since 10-23-82 under 510(k) number K802399. (Company formerly known as Medical Equipment Development Co., Inc.) as well as PURITAN BENNETT McSHIRLEY K801982 and SOUTH… | 1980 |
| * | K801982 | The Mcshirley PercussorSummary page 1…for hospitals since 10-23-82 under 510(k) number K802399. (Company formerly known as Medical Equipment Development Co., Inc.) as well as PURITAN BENNETT McSHIRLEY K801982 and SOUTHWEST MEDICAL MFG. INC (STROM)‘K821265, K821570 K813438 3 . Indications for Use (intended use) : The intended use of… | 1980 |
| * | K821265 | Pneumopulssor (PPS II)Summary page 1…er K802399. (Company formerly known as Medical Equipment Development Co., Inc.) as well as PURITAN BENNETT McSHIRLEY K801982 and SOUTHWEST MEDICAL MFG. INC (STROM)‘K821265, K821570 K813438 3 . Indications for Use (intended use) : The intended use of the Med Systems Electro Flo Percussor Model 50… | 1982 |
| * | K821570 | Pneumo Pulssor IiiSummary page 1…9. (Company formerly known as Medical Equipment Development Co., Inc.) as well as PURITAN BENNETT McSHIRLEY K801982 and SOUTHWEST MEDICAL MFG. INC (STROM)‘K821265, K821570 K813438 3 . Indications for Use (intended use) : The intended use of the Med Systems Electro Flo Percussor Model 5000 is pro… | 1982 |
| * | K813438 | Pneumo PulssorSummary page 1…any formerly known as Medical Equipment Development Co., Inc.) as well as PURITAN BENNETT McSHIRLEY K801982 and SOUTHWEST MEDICAL MFG. INC (STROM)‘K821265, K821570 K813438 3 . Indications for Use (intended use) : The intended use of the Med Systems Electro Flo Percussor Model 5000 is provide air… | 1981 |
What descends from it? (5)
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?
- None of the 5 ancestors has a recall.
- Of its descendants, K063645 (Dymedso, Inc., 2007) has gone furthest, with 3 descendants of its own.
How does its category compare?
All BYI devicesBYI Percussor, Powered-Electric: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 intended use of the Med Systems Electro Flo Percussor Model 5000 is the same as the predicate device, which is to provide airway clearance therapy when external manipulation of the thorax is the physician's choice of treatment. Indications for this form of therapy are described by the American Association for Respiratory Care (AARC) in the Clinical Practices Guidelines for Postural Drainage Therapy ('I (1991). According to AARC guidelines, specific…
Read the full statement (163 words)
The intended use of the Med Systems Electro Flo Percussor Model 5000 is the same as the predicate device, which is to provide airway clearance therapy when external manipulation of the thorax is the physician's choice of treatment. Indications for this form of therapy are described by the American Association for Respiratory Care (AARC) in the Clinical Practices Guidelines for Postural Drainage Therapy ('I (1991). According to AARC guidelines, specific indications for external manipulation of the thorax include evidence or a suggestion of retained secretions, evidence that the patient is having difficulty with the secretion clearance, or presence of atelectasis caused by mucus plugging. In addition, the Med Systems Electro Flo Percussor Model 5000 is also indicated for external manipulation of the thorax to promote airway clearance or improve bronchial drainage for purposes of collecting mucus for diagnostic evaluation.
(1). Bronchial Hygiene Guidelines Committee, American Association for Respiratory Care. AARC clinical practice guideline: postural drainage therapy. Respiratory Care 1991; 36: 1418 - 1426.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031876 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031876: Electro Flo Percussor, Model 5000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031876
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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