Zenith Technical Innovations: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Zenith Technical Innovations” (first 2018, latest 2024), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 70 days. Since 2017 the median was 70 days, against 132 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2018 | 1 | 94 |
| 2019 | 1 | 38 |
| 2020 | 1 | 70 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 28 |
| 2024 | 1 | 157 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Zenith Technical Innovations took a median 70 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 132 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IRP | Massager, Powered Inflatable Tube | 4 | 4 |
| JOW | Sleeve, Limb, Compressible | 1 | 1 |
Review panels
- Physical Medicine (4)
- Cardiovascular (1)
Most recent Zenith Technical Innovations 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K240125 | Therm-X (Home); Therm-X (AT) | JOW | 2024-06-21 | 157 |
| K231912 | Therm-X | IRP | 2023-07-27 | 28 |
| K193550 | Therm-X | IRP | 2020-02-28 | 70 |
| K190854 | Therm-X | IRP | 2019-05-10 | 38 |
| K181149 | Therm-X Pro, Therm-X AT, Therm-X Pro Athlete | IRP | 2018-08-03 | 94 |
Recalls
openFDA lists no recalls under a recalling firm named Zenith Technical Innovations.
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.
- Zenith Hearing Instrument Co. (1 510(k)s)
- Zenith-Omni H.C., Inc. (1 510(k)s)
- Zenith/Omni Hearing Instruments, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Zenith Technical Innovations?
FDA lists 5 510(k) clearances under the applicant name “Zenith Technical Innovations” (first 2018, latest 2024), across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Zenith Technical Innovations?
The median time from FDA receipt to decision across 510(k)s cleared under the name Zenith Technical Innovations is 70 days. Since 2017: 70 days, versus 132 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Zenith Technical Innovations?
The most frequent FDA product codes under this applicant name are IRP (Massager, Powered Inflatable Tube, 4); JOW (Sleeve, Limb, Compressible, 1).
Next steps
- See all 5 Zenith Technical Innovations clearances with predicates and recalls
- Run predicate analysis for product code IRP, Zenith Technical Innovations'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.