510(k) · Cleared
ClearedModel 2500 Pneumatic Percussor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Equipment Development Co., Inc. · BYI Percussor, Powered-Electric
Cleared on Oct 23, 1980 after a 21-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.
- Decided
- Oct 23, 1980
- Review
- 21 days
- Class
- Class II
- Product code
- BYI
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 1 citing it directly.
- This deviceK802399 Model 2500 Pneumatic PercussorMedical Equipment Development Co., Inc. · 1980
- Descendant · cites it directly · 5 of its ownK031876 Electro Flo Percussor, Model 5000Med Systems · 2003
- Descendant · 2 generations on · 3 of its ownK063645 Frequencer, Model 1001Dymedso, Inc. · 2007
- Descendant · 3 generations on · 2 of its ownK100749 Frequencer Model V2XDymedso, Inc. · 2010
- Descendant · 4 generations on · 1 of its ownK103176 FrequencerDymedso, Inc. · 2011
- Descendant · 2 generations on · 0 of its ownK201490 Electro Flo 6 Airway Clearance SystemMed Systems, Inc. · 2021
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K031876Electro Flo Percussor, Model 5000Med Systems · 2003 · cites it directly5descendants
- K063645Frequencer, Model 1001Dymedso, Inc. · 2007 · 2 generations on3descendants
- K100749Frequencer Model V2XDymedso, Inc. · 2010 · 3 generations on2descendants
- K103176FrequencerDymedso, Inc. · 2011 · 4 generations on1descendant
- K201490Electro Flo 6 Airway Clearance SystemMed Systems, Inc. · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K802399 | Model 2500 Pneumatic Percussor | Medical Equipment Development Co., Inc. | 1980 | — |
| +1 | K031876 | Electro Flo Percussor, Model 5000 | Med Systems | 2003 | — |
| +2 | K063645 | Frequencer, Model 1001 | Dymedso, Inc. | 2007 | — |
| +3 | K100749 | Frequencer Model V2X | Dymedso, Inc. | 2010 | — |
| +4 | K103176 | Frequencer | Dymedso, Inc. | 2011 | — |
| +2 | K201490 | Electro Flo 6 Airway Clearance System | Med Systems, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2021 | 1 | 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 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031876 | Electro Flo Percussor, Model 5000 | 2003 | 5 |
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, K031876 (Med Systems, 2003) has gone furthest, with 5 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 | — |
https://510kreport.com/device/K802399 · printed Nov 5, 2026
Cite this page
510(k) Report. “K802399: Model 2500 Pneumatic Percussor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K802399
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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