510(k) · Cleared
ClearedPhilip XP Series, in-the Canal Hearing Aid
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Hearing Instruments Co. · ESD Hearing Aid, Air-Conduction, Prescription
Cleared on Aug 11, 1992 after a 124-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 6 later devices descend from it.
- Decided
- Aug 11, 1992
- Review
- 124 days
- Class
- Class I
- Product code
- ESD
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 3 citing it directly.
- This deviceK921725 Philip XP Series, in-the Canal Hearing AidPhilips Hearing Instruments Co. · 1992
- Descendant · cites it directly · 4 of its ownK021867 Insound XT Series Hearing AidInsound Medical, Inc. · 2002
- Descendant · cites it directly · 2 of its ownK081136 Lyric Hearing AidInsound Medical, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 1 of its ownK130790 LYRIC2Phonak, LLC · 2013
- Descendant · 3 generations on · 0 of its ownK232999 Lyric4 Hearing AidSonova AG · 2024
- Descendant · 2 generations on · 0 of its ownK151025 iHearTestIhear Medical, Inc. · 2015
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K021867Insound XT Series Hearing AidInsound Medical, Inc. · 2002 · cites it directly4descendants
- K081136Lyric Hearing AidInsound Medical, Inc. · 2008 · cites it directly2descendants
- K130790LYRIC2Phonak, LLC · 2013 · 2 generations on1descendant
- K232999Lyric4 Hearing AidSonova AG · 2024 · 3 generations on0descendants
- K151025iHearTestIhear Medical, Inc. · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K921725 | Philip XP Series, in-the Canal Hearing Aid | Philips Hearing Instruments Co. | 1992 | — |
| +1 | K021867 | Insound XT Series Hearing Aid | Insound Medical, Inc. | 2002 | — |
| +1 | K081136 | Lyric Hearing Aid | Insound Medical, Inc. | 2008 | 1 |
| +2 | K130790 | LYRIC2 | Phonak, LLC | 2013 | — |
| +3 | K232999 | Lyric4 Hearing Aid | Sonova AG | 2024 | — |
| +2 | K151025 | iHearTest | Ihear Medical, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2002 | 1 | 0 |
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2024 | 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 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (6)
3 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, K021867 (Insound Medical, Inc., 2002) has gone furthest, with 4 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/K921725 · printed Nov 6, 2026
Cite this page
510(k) Report. “K921725: Philip XP Series, in-the Canal Hearing Aid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K921725
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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