ZetrOZ Systems, LLC: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “ZetrOZ Systems, LLC” (first 2020, latest 2026), across 1 product code in 1 review panel. Median 510(k) review time under this name: 106 days. Since 2017 the median was 106 days, against 158 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 |
|---|---|---|
| 2020 | 1 | 267 |
| 2021 | 1 | 96 |
| 2022 | 0 | — |
| 2023 | 2 | 147 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 1 | 106 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name ZetrOZ Systems, LLC took a median 106 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 158 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PFW | Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat | 5 | 5 |
Review panels
Most recent ZetrOZ Systems, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260076 | SAM 3.0 Multi-Hour Continuous Ultrasound Device | PFW | 2026-04-28 | 106 |
| K233210 | sam CS Long Duration Ultrasound Device | PFW | 2023-10-25 | 27 |
| K223019 | sam 2.0 Long Ultrasound Device | PFW | 2023-06-23 | 267 |
| K211513 | sam X1 Long Duration Ultrasound Device | PFW | 2021-08-18 | 96 |
| K191568 | sam 2.0 Long Duration Ultrasound System | PFW | 2020-03-06 | 267 |
Recalls
openFDA lists no recalls under a recalling firm named ZetrOZ Systems, LLC.
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.
- Zetroz, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under ZetrOZ Systems, LLC?
FDA lists 5 510(k) clearances under the applicant name “ZetrOZ Systems, LLC” (first 2020, latest 2026), 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 ZetrOZ Systems, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name ZetrOZ Systems, LLC is 106 days. Since 2017: 106 days, versus 158 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under ZetrOZ Systems, LLC?
The most frequent FDA product codes under this applicant name are PFW (Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat, 5).
Next steps
- See all 5 ZetrOZ Systems, LLC clearances with predicates and recalls
- Run predicate analysis for product code PFW, ZetrOZ Systems, LLC'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.