Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
LZW · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
191 daysmedian FDA review time
269 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K093553 | POSTURETEK | Perseus Althetics,Llc | 2010-08-13 | 269 | 0 |
| K081540 | ZEGRA POSTURE TRAINER | Peter Fischer | 2009-02-20 | 263 | 0 |
| K951244 | SPINE TUNER POSTURE TRAINER | Dan Kline | 1995-06-26 | 105 | 0 |
| K902669 | BPA, BODY POSITION ALARM | Bagrad | 1990-07-27 | 39 | 0 |
| K884976 | MICRO-STRAIGHT POSTURE TRAINING DEVICE | Mcdowell Ent., Inc. | 1989-06-09 | 191 | 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