Itl Corporation Pty, Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Itl Corporation Pty, Ltd.” (first 1999, latest 2016), across 4 product codes in 4 review panels. Median 510(k) review time under this name: 33 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 | 1 | 204 |
| 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 |
|---|---|---|---|
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | 2 | 2 |
| FMI | Needle, Hypodermic, Single Lumen | 1 | 1 |
| HAM | Apparatus, Electrosurgical | 1 | 1 |
| HIB | Speculum, Vaginal, Nonmetal | 1 | 1 |
Review panels
- Clinical Chemistry (2)
- General Hospital (1)
- Obstetrics and Gynecology (1)
- General and Plastic Surgery (1)
Most recent Itl Corporation Pty, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K153472 | Quiver Laparoscopic Extendable | HAM | 2016-06-23 | 204 |
| K021941 | SAMPLOK LUER KIT | JKA | 2002-07-02 | 19 |
| K021017 | LEESPEC DISPOSABLE VAGINAL SPECULUM | HIB | 2002-06-19 | 82 |
| K000777 | SAMPLOK | JKA | 2000-04-11 | 33 |
| K991404 | PLATYPUS AV FISTULA NEEDLE PROTECTOR (AVFNP) | FMI | 1999-05-14 | 22 |
Recalls
openFDA lists no recalls under a recalling firm named Itl Corporation Pty, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Itl Corporation Pty, Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Itl Corporation Pty, Ltd.” (first 1999, latest 2016), across 4 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 Itl Corporation Pty, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Itl Corporation Pty, Ltd. is 33 days.
Which FDA product codes appear under Itl Corporation Pty, Ltd.?
The most frequent FDA product codes under this applicant name are JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection, 2); FMI (Needle, Hypodermic, Single Lumen, 1); HAM (Apparatus, Electrosurgical, 1).
Next steps
- See all 5 Itl Corporation Pty, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code JKA, Itl Corporation Pty, 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.