Sound Health Systems, Inc.: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Sound Health Systems, Inc.” (first 2025, latest 2025), plus 1 De Novo decision, across 1 product code in 1 review panel. Median 510(k) review time under this name: 269 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2025 | 1 | 269 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Sound Health Systems, Inc. took a median 269 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 269 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QZC | External Mechanical Stimulator For The Relief Of Congestion | 2 | 1 |
Review panels
Most recent Sound Health Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K242214 | Sonu | QZC | 2025-04-24 | 269 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN230045 | De Novo | External Mechanical Stimulator For The Relief Of Congestion | 2023-12-04 |
Recalls
openFDA lists no recalls under a recalling firm named Sound Health Systems, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Sound Surgical Technologies, LLC (6 510(k)s)
- Sound 2000 Medical Systems, Inc. (1 510(k)s)
- Sound Acoustic Systems, Ltd. (1 510(k)s)
- Sound Crafters Hearing Instruments (1 510(k)s)
- Sound Hearing Instruments, Inc. (1 510(k)s)
- Sound Imaging, Inc. (1 510(k)s)
- Sound Land Corp. (1 510(k)s)
- Sound Life Sciences, Inc. (1 510(k)s)
- Sound Linked Data, Inc. (1 510(k)s)
- Sound Options Tinnitus Treatments, Inc. (1 510(k)s)
- Sound Technique System, LLC (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Sound Health Systems, Inc.?
FDA lists 1 510(k) clearance under the applicant name “Sound Health Systems, Inc.” (first 2025, latest 2025), plus 1 De Novo decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Sound Health Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sound Health Systems, Inc. is 269 days.
Which FDA product codes appear under Sound Health Systems, Inc.?
The most frequent FDA product codes under this applicant name are QZC (External Mechanical Stimulator For The Relief Of Congestion, 2).
Next steps
- See all 1 Sound Health Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code QZC, Sound Health Systems, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.