Setma, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Setma, Inc.” (first 1984, latest 1986), across 3 product codes in 3 review panels. Median 510(k) review time under this name: 34 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ILJ | Bath, Hydro-Massage | 4 | 4 |
| FSA | Lift, Patient, Non-Ac-Powered | 2 | 2 |
| FDA | Enteroscope And Accessories | 1 | 1 |
Review panels
Most recent Setma, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K854861 | SETMA HYGIA BATH MODEL ST 7200 | ILJ | 1986-01-03 | 29 |
| K854263 | SETMA FHT, MODEL ST 8130 | ILJ | 1985-11-13 | 21 |
| K853163 | SETMA VHT | ILJ | 1985-11-05 | 98 |
| K841397 | BURN BATH | ILJ | 1984-05-18 | 45 |
| K841398 | VARIABLE HEIGHT TRANSFER CHAIR | FSA | 1984-05-07 | 34 |
| K841396 | TRANSFER TROLLEY | FDA | 1984-05-07 | 34 |
| K841395 | SHOWER TROLLEY | FSA | 1984-05-07 | 34 |
Recalls
openFDA lists no recalls under a recalling firm named Setma, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Setma, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Setma, Inc.” (first 1984, latest 1986), across 3 product codes in 3 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 Setma, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Setma, Inc. is 34 days.
Which FDA product codes appear under Setma, Inc.?
The most frequent FDA product codes under this applicant name are ILJ (Bath, Hydro-Massage, 4); FSA (Lift, Patient, Non-Ac-Powered, 2); FDA (Enteroscope And Accessories, 1).
Next steps
- See all 7 Setma, Inc. clearances with predicates and recalls
- Run predicate analysis for product code ILJ, Setma, 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 (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.