Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KNL · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
17 daysmedian FDA review time
19 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K841695 | CRAWLER | Maddak, Inc. | 1984-05-10 | 17 | 0 |
| K811489 | SCOOTER BOARD | Fred Sammons, Inc. | 1981-06-12 | 17 | 0 |
| K790528 | THERAPY GYROSCOPE | Maddak, Inc. | 1979-04-03 | 19 | 0 |
| K781198 | BOARD, SCOOTER | Fred Sammons, Inc. | 1978-07-31 | 17 | 0 |
| K780296 | THERAPY SCOOTER | Convaid Product Development | 1978-02-24 | 3 | 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