510(k) · Cleared
ClearedResound Portable Prescriptive Programming System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Resound Corp. · EWO Audiometer
Cleared on Sep 16, 1991 after a 90-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 36 later devices descend from it.
- Decided
- Sep 16, 1991
- Review
- 90 days
- Class
- Class II
- Product code
- EWO
- Recalls
- None
- Predicates
- 0
36 later devices descend from it, 2 citing it directly.
- This deviceK912669 Resound Portable Prescriptive Programming SystemResound Corp. · 1991
- Descendant · cites it directly · 34 of its ownK984547 Digital Lgob Procedure Using Resound, Digital 5000 Series Hearing AidsResound Corp. · 1999
- Descendant · 2 generations on · 33 of its ownK090720 Cochlear Baha BP100Cochlear Bone Anchored Systems AB · 2009
- Descendant · 3 generations on · 11 of its ownK132278 Cochlear Baha 4 Sound ProcessorCochlear Americas · 2013
- Descendant · 3 generations on · 11 of its ownK103594 Ponto Pro PowerOticon Medical AB · 2011
- Descendant · 4 generations on · 10 of its ownK142907 Baha 5 Sound ProcessorCochlear Americas · 2015 · Recalled
Showing 5 of 36 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 36 · See all- K984547Digital Lgob Procedure Using Resound, Digital 5000 Series Hearing AidsResound Corp. · 1999 · cites it directly34descendants
- K090720Cochlear Baha BP100Cochlear Bone Anchored Systems AB · 2009 · 2 generations on33descendants
- K132278Cochlear Baha 4 Sound ProcessorCochlear Americas · 2013 · 3 generations on11descendants
- K103594Ponto Pro PowerOticon Medical AB · 2011 · 3 generations on11descendants
- K142907Baha 5 Sound ProcessorCochlear Americas · 2015 · 4 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K912669 | Resound Portable Prescriptive Programming System | Resound Corp. | 1991 | — |
| +1 | K984547 | Digital Lgob Procedure Using Resound, Digital 5000 Series Hearing Aids | Resound Corp. | 1999 | — |
| +2 | K090720 | Cochlear Baha BP100 | Cochlear Bone Anchored Systems AB | 2009 | — |
| +3 | K132278 | Cochlear Baha 4 Sound Processor | Cochlear Americas | 2013 | — |
| +3 | K103594 | Ponto Pro Power | Oticon Medical AB | 2011 | — |
| +4 | K142907 | Baha 5 Sound Processor | Cochlear Americas | 2015 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 4 | 0 |
| 2012 | 1 | 0 |
| 2013 | 4 | 0 |
| 2015 | 3 | 0 |
| 2016 | 5 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 5 | 0 |
| 2025 | 2 | 0 |
| 2026 | 4 | 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 EWO? 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 EWO device
- #1 K234095 OtoNova/OtoNova Proscore 9.3 · 7 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (36)
See all 362 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?
- Of its descendants, K984547 (Resound Corp., 1999) has gone furthest, with 34 descendants of its own.
How does its category compare?
All EWO devicesEWO Audiometer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EWO
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · EWO
173in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EWO
4in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EWO
13in 2025
MAUDE reports naming product code EWO, 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 | 5 | 69 | 0 | 1 |
| 2008 | 1 | — | 1 | 1 |
| 2009 | 2 | — | 0 | 1 |
| 2010 | 2 | — | 0 | 4 |
| 2011 | 3 | 151 | 0 | 2 |
| 2012 | 4 | 137 | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 4 | 173 | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 7 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 1 | — | 0 | 6 |
| 2023 | 1 | — | 4 | 3 |
| 2024 | 2 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 13 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K912669 · printed Nov 5, 2026
Cite this page
510(k) Report. “K912669: Resound Portable Prescriptive Programming System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K912669
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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