Australian Biomedical Corporation , Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Australian Biomedical Corporation , Ltd.” (first 1985, latest 1987), across 5 product codes in 5 review panels. Median 510(k) review time under this name: 29 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 |
|---|---|---|---|
| FPP | Stretcher, Hand-Carried | 1 | 1 |
| GAD | Retractor | 1 | 1 |
| HLJ | Ophthalmoscope, Battery-Powered | 1 | 1 |
| IDZ | Cassettes, Tissue | 1 | 1 |
| ITH | Equipment, Traction, Powered | 1 | 1 |
Review panels
- General Hospital (1)
- Ophthalmic (1)
- Pathology (1)
- Physical Medicine (1)
- General and Plastic Surgery (1)
Most recent Australian Biomedical Corporation , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K871735 | VOROSCOPE(TM) | HLJ | 1987-06-03 | 29 |
| K862457 | LYNX EL MICROSCOPY TISSUE PROCESSOR | IDZ | 1986-07-16 | 16 |
| K851660 | DONWAY LIFTING FRAME | FPP | 1985-08-07 | 106 |
| K853114 | ROTALOK WRIST STRAP, ROTALOK SKIN RETRACTOR | GAD | 1985-08-06 | 13 |
| K843522 | DONWAY SPLINT | ITH | 1985-02-07 | 153 |
Recalls
openFDA lists no recalls under a recalling firm named Australian Biomedical Corporation , Ltd..
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Australian Optical Co., Inc. (8 510(k)s)
- Australian Surgical Design & Manufacture (1 510(k)s)
- Australian Surgical Devices (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Australian Biomedical Corporation , Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Australian Biomedical Corporation , Ltd.” (first 1985, latest 1987), across 5 product codes in 5 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 Australian Biomedical Corporation , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Australian Biomedical Corporation , Ltd. is 29 days.
Which FDA product codes appear under Australian Biomedical Corporation , Ltd.?
The most frequent FDA product codes under this applicant name are FPP (Stretcher, Hand-Carried, 1); GAD (Retractor, 1); HLJ (Ophthalmoscope, Battery-Powered, 1).
Next steps
- See all 5 Australian Biomedical Corporation , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code FPP, Australian Biomedical Corporation , Ltd.'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.