Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Go Medical Industries Pty. , Ltd. · Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
102 daysmedian FDA review time
254 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K011055 | THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADS | Go Medical Industries Pty. , Ltd. | 2001-06-06 | 61 | 0 |
| K002803 | THE O'NEIL STERILE FIELD URINARY CATHETER KIT | Go Medical Industries Pty. , Ltd. | 2000-12-27 | 110 | 5 |
| K000263 | GO MEDICAL BALLOON INFUSION SYSTEM | Go Medical Industries Pty. , Ltd. | 2000-05-09 | 102 | 0 |
| K910007 | SPRINGFUSOR 10R | Go Medical Industries Pty. , Ltd. | 1993-11-02 | 1035 | 0 |
| K900336 | V SET | Go Medical Industries Pty. , Ltd. | 1990-10-04 | 254 | 0 |
| K895594 | SINGLE LUMEN O'NEIL ASPIRATION & IRRIGATION NEEDLE | Go Medical Industries Pty. , Ltd. | 1989-10-06 | 21 | 0 |
| K890400 | MODIFIED URINARY CATHETER INTRODUCER (UCI) | Go Medical Industries Pty. , Ltd. | 1989-09-12 | 231 | 0 |
| K891465 | OBSTETRIC CUP (MODIFICATION) | Go Medical Industries Pty. , Ltd. | 1989-05-11 | 57 | 0 |
| K885283 | ASPIRATING AND IRRIGATING CYSTS NEEDLES | Go Medical Industries Pty. , Ltd. | 1989-03-22 | 92 | 0 |
| K850758 | AMNIGLOVE & AMNICOT | Go Medical Industries Pty. , Ltd. | 1985-04-15 | 49 | 0 |
| K840008 | O'NEIL OBSTETRIC CUP | Go Medical Industries Pty. , Ltd. | 1984-04-25 | 112 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda