Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bodystat , Ltd. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
259 daysmedian FDA review time
913 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K082254 | MODIFICATION TO BODYSTAT 1500MDD BODY COMPOSITION MONITORING | Bodystat , Ltd. | 2011-02-07 | 913 | 0 |
| K082255 | QUADSCAN 4000 BODY BODY COMPOSITION, FLUID & ILLNESS/SEGMENT | Bodystat , Ltd. | 2011-02-07 | 913 | 0 |
| K082253 | BODYSTAT 1500 BODY COMPOSITION MONITORING UNIT | Bodystat , Ltd. | 2008-11-25 | 109 | 0 |
| K002835 | BODYSTAT | Bodystat , Ltd. | 2001-07-03 | 294 | 0 |
| K994242 | BODYSTAT 1500MDD BODY COMPOSITION MONITORING UNIT | Bodystat , Ltd. | 2000-03-15 | 90 | 0 |
| K980971 | BODYSTAT DUALSCAN 2005 | Bodystat , Ltd. | 1998-06-11 | 87 | 0 |
| K971554 | BODYSTAT | Bodystat , Ltd. | 1997-11-26 | 210 | 0 |
| K951097 | BODYSTAY | Bodystat , Ltd. | 1995-11-22 | 259 | 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