Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
PLB · Predicate Candidate Screening
8 FDA 510(k) clearances under this product code; the 50 most recent screened below.
262 daysmedian FDA review time
443 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K240756 | AITRICS-VC | Aitrics Co., Ltd. | 2024-07-23 | 125 | 0 |
| K240558 | NAVOYCDS | Algodx AB | 2024-07-22 | 145 | 0 |
| K230386 | SpassageQ | Spass, Inc. | 2023-06-15 | 121 | 0 |
| K213423 | T3 Platform software | Etiometry, Inc. | 2023-01-06 | 443 | 0 |
| K183282 | Biovitals Analytics Engine | Biofourmis Singapore Pte., Ltd. | 2019-08-15 | 262 | 0 |
| K152258 | T3 Software | Etiometry, Inc. | 2016-03-31 | 233 | 0 |
| K142512 | Personalized Physiology Analytics Engine software | Vgbio, Inc (Dba Physiq) | 2015-06-11 | 276 | 0 |
| K843905 | TRAUMA CARE EVALUATION | Quantitative | 1985-09-26 | 358 | 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