Orthion Corp.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Orthion Corp.” (first 1981, latest 1983), across 9 product codes in 2 review panels. Median 510(k) review time under this name: 16 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 |
|---|---|---|---|
| IKX | Aid, Transfer | 2 | 2 |
| ILS | Adaptor, Hygiene | 2 | 2 |
| ILE | Sling, Arm, Overhead Supported | 1 | 1 |
| INM | Chair, With Casters | 1 | 1 |
| INQ | Table, Powered | 1 | 1 |
| INW | Table, Mechanical | 1 | 1 |
| IPF | Stimulator, Muscle, Powered | 1 | 1 |
| ITJ | Walker, Mechanical | 1 | 1 |
| IYM | System, Telethermographic, Infrared | 1 | 1 |
Review panels
- Physical Medicine (10)
- Radiology (1)
Most recent Orthion Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K832546 | MARK V HIGH VOLTAGE GALVANIC STIMULATORR | IPF | 1983-10-14 | 77 |
| K823156 | COLLAPSABLE LAVATORY HEIGHTENER | ILS | 1982-11-05 | 16 |
| K823155 | LAVATORY SEAT HEIGHTENER | ILS | 1982-11-05 | 16 |
| K823154 | SHOWER STOOL W/HANDLES | IKX | 1982-11-05 | 16 |
| K823153 | BATH TUB SEAT & BATH BOARD | IKX | 1982-11-05 | 16 |
| K823152 | OB HELP ARM | ILE | 1982-11-05 | 16 |
| K823151 | OB TRIPP TRANSPORT CHAIR | INM | 1982-11-05 | 16 |
| K823150 | SESAM TREATMENT TABLE | INQ | 1982-11-05 | 16 |
| K823149 | OB TILT TABLE | INW | 1982-11-05 | 16 |
| K823105 | RESI-WALKER | ITJ | 1982-11-05 | 16 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Orthion Corp..
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 Orthion Corp.?
FDA lists 11 510(k) clearances under the applicant name “Orthion Corp.” (first 1981, latest 1983), across 9 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 Orthion Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Orthion Corp. is 16 days.
Which FDA product codes appear under Orthion Corp.?
The most frequent FDA product codes under this applicant name are IKX (Aid, Transfer, 2); ILS (Adaptor, Hygiene, 2); ILE (Sling, Arm, Overhead Supported, 1).
Next steps
- See all 11 Orthion Corp. clearances with predicates and recalls
- Run predicate analysis for product code IKX, Orthion Corp.'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.