Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Body Therapeutics, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
28 daysmedian FDA review time
38 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K831582 | VARI-SUPPORT NECK POSTURE PILLOW | Body Therapeutics, Inc. | 1983-06-15 | 29 | 0 |
| K821836 | PREGNANCY (W) EDGE | Body Therapeutics, Inc. | 1982-07-30 | 38 | 0 |
| K821837 | VARI-SUPPORT NECK POSTURE PILLOW | Body Therapeutics, Inc. | 1982-07-20 | 28 | 0 |
| K821838 | VARI-SUPPORT LOW BACK POSTURE PILLOW | Body Therapeutics, Inc. | 1982-07-20 | 28 | 0 |
| K802442 | LOW BACK POSTURE PILLOW | Body Therapeutics, Inc. | 1980-10-31 | 24 | 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