Lic-Orthion: FDA filings under this applicant name
FDA lists 17 510(k) clearances under the applicant name “Lic-Orthion” (first 1983, latest 1989), across 12 product codes in 4 review panels. Median 510(k) review time under this name: 19 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 |
|---|---|---|---|
| EYQ | Garment, Protective, For Incontinence | 2 | 2 |
| ILC | Utensil, Eating | 2 | 2 |
| ILS | Adaptor, Hygiene | 2 | 2 |
| INQ | Table, Powered | 2 | 2 |
| KNX | Collector, Urine, (And Accessories) For Indwelling Catheter | 2 | 2 |
| ECG | Sterilizer, Boiling Water | 1 | 1 |
| ILE | Sling, Arm, Overhead Supported | 1 | 1 |
| INM | Chair, With Casters | 1 | 1 |
| ITJ | Walker, Mechanical | 1 | 1 |
| JFB | Table, Physical Therapy, Multi Function | 1 | 1 |
Plus 2 more product codes.
Review panels
- Physical Medicine (10)
- Gastroenterology and Urology (4)
- Dental (2)
- General Hospital (1)
Most recent Lic-Orthion 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K891649 | PATIENT EXAMINATION GLOVES (LATEX) | LYY | 1989-04-04 | 18 |
| K862022 | LIC-ORTHION MULTI-THERAPY TREATMENT TABLE | JFB | 1986-06-19 | 22 |
| K854730 | DAISY (ABSORBENT INCONTINENCE SHIELD) | EYQ | 1986-02-06 | 73 |
| K854729 | ADAM (ABSORBENT INCONTINENCE SHIELD) | EYQ | 1986-02-06 | 73 |
| K851471 | TRIBAG, TRIBAND & TRIFIX-REUSEABLE URINE COLLECTOR | KNX | 1985-06-12 | 58 |
| K851470 | BIBAG, BIBAND & BIFIX - SINGLE USE URINE COLLECTOR | KNX | 1985-06-12 | 58 |
| K843234 | CITOMAT AUTOCLAVES | ECG | 1984-10-25 | 69 |
| K843233 | ANATOM SYSTEM | KLC | 1984-10-25 | 69 |
| K830853 | LAVATORY SEAT HEIGHTENER | ILS | 1983-06-08 | 83 |
| K830855 | SESAM TREATMENT TABLE | INQ | 1983-04-05 | 19 |
7 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Lic-Orthion.
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 Lic-Orthion?
FDA lists 17 510(k) clearances under the applicant name “Lic-Orthion” (first 1983, latest 1989), across 12 product codes in 4 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 Lic-Orthion?
The median time from FDA receipt to decision across 510(k)s cleared under the name Lic-Orthion is 19 days.
Which FDA product codes appear under Lic-Orthion?
The most frequent FDA product codes under this applicant name are EYQ (Garment, Protective, For Incontinence, 2); ILC (Utensil, Eating, 2); ILS (Adaptor, Hygiene, 2).
Next steps
- See all 17 Lic-Orthion clearances with predicates and recalls
- Run predicate analysis for product code EYQ, Lic-Orthion'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.