Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
IPT · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
25 daysmedian FDA review time
154 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K963091 | VOLLMAN PRONE POSITIONER | Hill-Rom, Inc. | 1997-01-09 | 154 | 0 |
| K821645 | BACK SKPPORTS | Fred Sammons, Inc. | 1982-06-11 | 8 | 0 |
| K812401 | CRUCIFORM ANTERIOR SPINAL HYPEREXTEN. O | Surgical Appliance Industries, Inc. | 1981-09-14 | 25 | 0 |
| K811750 | MULTITUBULAR THORACIC AIR SPLINTS | Roger Cestac & Assoc. | 1981-07-20 | 28 | 0 |
| K761128 | LATERAL TRUNK SUPPORTS | Fred Sammons, Inc. | 1976-12-02 | 13 | 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