Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
QME — Predicate Candidate Screening
13 FDA 510(k) clearances under this product code; the 50 most recent screened below.
203 daysmedian FDA review time
290 days90th percentile
13clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K254169 | SmartSpectra Vital Signs Monitor 1.0 | Presage Security, Inc. d/b/a Presage Technologies, Inc. | 2026-06-18 | 177 | 0 |
| K253650 | Anura Mobile Core SDK (M1) | Nuralogix Corporation | 2026-06-11 | 203 | 0 |
| K260066 | PanopticAI Vital Signs (1.6.1-22) | PanopticAI Technologies Limited | 2026-05-21 | 132 | 0 |
| K251200 | Vital Signs | Oxehealth Limited | 2026-02-02 | 290 | 0 |
| K243687 | Vital Signs | Oxehealth Limited | 2025-08-27 | 271 | 0 |
| K250078 | Informed Vital Core Application (IVC App) (v2.0.0.2.0.0) | Mindset Medical, Inc. | 2025-05-30 | 137 | 0 |
| K240890 | PanopticAI Vital Signs | PanopticAI technologies Limited | 2024-12-23 | 266 | 0 |
| K241633 | Informed Vital Core Application (IVC App) | Mindset Medical, Inc. | 2024-11-18 | 165 | 0 |
| K232804 | FibriCheck | Qompium NV | 2024-06-07 | 269 | 0 |
| K223622 | FaceHeart Vitals Software Development Kit (FH vitals SDK) | Faceheart Corp. | 2023-09-01 | 270 | 0 |
| K220899 | Oxehealth Vital Signs | Oxehealth Limited | 2022-04-29 | 32 | 0 |
| K211906 | Vital Signs | Oxehealth Limited | 2021-07-20 | 29 | 0 |
| DEN200019 | Oxehealth Vital Signs | Oxehealth Limited | 2021-03-26 | 364 | 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