Orthomerica Products, Inc.: FDA filings under this applicant name
FDA lists 21 510(k) clearances under the applicant name “Orthomerica Products, Inc.” (first 2000, latest 2024), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 86 days. Since 2017 the median was 105 days, against 188 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 164 |
| 2014 | 3 | 90 |
| 2015 | 3 | 63 |
| 2016 | 1 | 89 |
| 2017 | 0 | — |
| 2018 | 1 | 44 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 2 | 150 |
| 2022 | 0 | — |
| 2023 | 1 | 182 |
| 2024 | 1 | 28 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Orthomerica Products, Inc. took a median 105 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 188 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OAN | Orthosis, Cranial, Laser Scan | 17 | 17 |
| MVA | Orthosis, Cranial | 4 | 4 |
Review panels
- Neurology (21)
Most recent Orthomerica Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K240466 | STARband 3D | OAN | 2024-03-15 | 28 |
| K223238 | STARband 3D | MVA | 2023-04-20 | 182 |
| K211376 | STARband | OAN | 2021-08-17 | 105 |
| K203098 | STARband, STARlight, St. Louis Band | OAN | 2021-04-27 | 195 |
| K180109 | STARband, STARlight, St. Louis Band | OAN | 2018-03-01 | 44 |
| K161138 | St. Louis Band | OAN | 2016-07-20 | 89 |
| K151979 | STARband, STARlight | OAN | 2015-09-18 | 63 |
| K151147 | STARband, STARlight | OAN | 2015-07-01 | 62 |
| K142141 | STARBAND, STARLIGHT | OAN | 2015-04-23 | 261 |
| K141842 | STARBAND, STARLIGHT | MVA | 2014-10-06 | 90 |
11 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Orthomerica Products, 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 Orthomerica Products, Inc.?
FDA lists 21 510(k) clearances under the applicant name “Orthomerica Products, Inc.” (first 2000, latest 2024), across 2 product codes 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 Orthomerica Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Orthomerica Products, Inc. is 86 days. Since 2017: 105 days, versus 188 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Orthomerica Products, Inc.?
The most frequent FDA product codes under this applicant name are OAN (Orthosis, Cranial, Laser Scan, 17); MVA (Orthosis, Cranial, 4).
Next steps
- See all 21 Orthomerica Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code OAN, Orthomerica Products, 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.