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. · ESD Hearing Aid, Air-Conduction, Prescription
Cleared on Nov 3, 1993 after a 231-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 35 later devices descend from it.
- Decided
- Nov 3, 1993
- Review
- 231 days
- Class
- Class I
- Product code
- ESD
- Recalls
- None
- Predicates
- 0
35 later devices descend from it, 2 citing it directly.
- This deviceK931372 Resound Portable Prescriptive Programming SystemResound Corp. · 1993
- Descendant · cites it directly · 34 of its ownK973880 Sonix Hearing Aid Fitting and Programming SystemSonix Technologies, Inc. · 1998
- Descendant · cites it directly · 33 of its ownK090720 Cochlear Baha BP100Cochlear Bone Anchored Systems AB · 2009
- Descendant · 2 generations on · 11 of its ownK132278 Cochlear Baha 4 Sound ProcessorCochlear Americas · 2013
- Descendant · 2 generations on · 11 of its ownK103594 Ponto Pro PowerOticon Medical AB · 2011
- Descendant · 3 generations on · 10 of its ownK142907 Baha 5 Sound ProcessorCochlear Americas · 2015 · Recalled
Showing 5 of 35 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 35 · See all- K973880Sonix Hearing Aid Fitting and Programming SystemSonix Technologies, Inc. · 1998 · cites it directly34descendants
- K090720Cochlear Baha BP100Cochlear Bone Anchored Systems AB · 2009 · cites it directly33descendants
- K132278Cochlear Baha 4 Sound ProcessorCochlear Americas · 2013 · 2 generations on11descendants
- K103594Ponto Pro PowerOticon Medical AB · 2011 · 2 generations on11descendants
- K142907Baha 5 Sound ProcessorCochlear Americas · 2015 · 3 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K931372 | Resound Portable Prescriptive Programming System | Resound Corp. | 1993 | — |
| +1 | K973880 | Sonix Hearing Aid Fitting and Programming System | Sonix Technologies, Inc. | 1998 | — |
| +1 | K090720 | Cochlear Baha BP100 | Cochlear Bone Anchored Systems AB | 2009 | — |
| +2 | K132278 | Cochlear Baha 4 Sound Processor | Cochlear Americas | 2013 | — |
| +2 | K103594 | Ponto Pro Power | Oticon Medical AB | 2011 | — |
| +3 | K142907 | Baha 5 Sound Processor | Cochlear Americas | 2015 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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 ESD? 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 ESD device
- #1 K232999 Lyric4 Hearing Aidscore 8.4 · 5 generations · no Class I recall
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? (35)
See all 352 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, K973880 (Sonix Technologies, Inc., 1998) has gone furthest, with 34 descendants of its own.
How does its category compare?
All ESD devicesESD Hearing Aid, Air-Conduction, Prescription: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ESD
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · ESD
Too few ESD 510(k)s in any year since 2007 to give a median.
Recalls per year · ESD
2in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ESD
53in 2025
MAUDE reports naming product code ESD, 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 | 0 | — | 0 | 13 |
| 2008 | 1 | — | 0 | 13 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 0 | — | 1 | 1 |
| 2011 | 0 | — | 0 | 3 |
| 2012 | 0 | — | 0 | 6 |
| 2013 | 1 | — | 0 | 37 |
| 2014 | 0 | — | 0 | 4 |
| 2015 | 0 | — | 0 | 6 |
| 2016 | 0 | — | 0 | 7 |
| 2017 | 0 | — | 0 | 4 |
| 2018 | 0 | — | 1 | 12 |
| 2019 | 0 | — | 2 | 9 |
| 2020 | 0 | — | 0 | 5 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 8 |
| 2024 | 1 | — | 0 | 16 |
| 2025 | 0 | — | 0 | 53 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K931372 · printed Nov 5, 2026
Cite this page
510(k) Report. “K931372: 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/K931372
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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