Orthion Corp.: FDA clearances and approvals
Orthion Corp. has 11 FDA 510(k) clearances (first 1981, latest 1983), across 9 product codes in 2 review panels. Median 510(k) review time: 16 days.
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 company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Orthion Corp. have?
Orthion Corp. has 11 FDA 510(k) clearances (first 1981, latest 1983), across 9 product codes in 2 review panels.
How long does FDA take to clear Orthion Corp.'s 510(k)s?
The median time from FDA receipt to decision across Orthion Corp.'s cleared 510(k)s is 16 days.
What devices does Orthion Corp. make?
Its most frequent FDA product codes are IKX (Aid, Transfer, 2); ILS (Adaptor, Hygiene, 2); ILE (Sling, Arm, Overhead Supported, 1).
Has Orthion Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Orthion Corp. Related entities may recall under other names.
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. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.