Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Annalise-Ai Pty , Ltd. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
165 daysmedian FDA review time
249 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K231767 | Annalise Enterprise CTB Triage Trauma | Annalise-Ai Pty , Ltd. | 2023-09-22 | 98 | 0 |
| K231384 | Annalise Enterprise CTB Triage Trauma | Annalise-Ai Pty , Ltd. | 2023-09-22 | 133 | 0 |
| K231094 | Annalise Enterprise CTB Triage-OH | Annalise-Ai Pty , Ltd. | 2023-08-15 | 119 | 0 |
| K223240 | Annalise Enterprise CTB Triage Trauma | Annalise-Ai Pty , Ltd. | 2023-04-03 | 165 | 0 |
| K222179 | Annalise Enterprise CXR Triage Trauma | Annalise-Ai Pty , Ltd. | 2023-03-28 | 249 | 0 |
| K222268 | Annalise Enterprise CXR Triage Trauma | Annalise-Ai Pty , Ltd. | 2023-03-28 | 243 | 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