Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
IKW — Predicate Candidate Screening
12 FDA 510(k) clearances under this product code; the 50 most recent screened below.
22 daysmedian FDA review time
27 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K831545 | REACHER & DOOR OPENER | Fred Sammons, Inc. | 1983-06-08 | 27 | 0 |
| K823605 | PORTABLE ELECTRIC CAN OPENER | Fred Sammons, Inc. | 1982-12-28 | 22 | 0 |
| K823607 | CARPET SWEEPER | Fred Sammons, Inc. | 1982-12-28 | 22 | 0 |
| K823633 | TURNERS FOR KNOBS | Fred Sammons, Inc. | 1982-12-28 | 22 | 0 |
| K821646 | TINY FLEX-GLASS, SET OF 4 | Fred Sammons, Inc. | 1982-06-11 | 8 | 0 |
| K813631 | JAR HOLDER & OPENER | Fred Sammons, Inc. | 1982-01-19 | 21 | 0 |
| K810454 | HOMEMAKING UTENSILS | Fred Sammons, Inc. | 1981-03-04 | 13 | 0 |
| K790173 | BK-5371 GAD-19-BOUT PERSONAL MOBIL AID | Fred Sammons, Inc. | 1979-02-22 | 27 | 0 |
| K761122 | PRUNING SCISSORS | Fred Sammons, Inc. | 1976-12-02 | 13 | 0 |
| K761115 | ROLLING PIN | Fred Sammons, Inc. | 1976-12-02 | 13 | 0 |
| K761124 | WEED PULLER & PRUNER | Fred Sammons, Inc. | 1976-12-02 | 13 | 0 |
| K760294 | LEVERS, DOOR KNOB, BK-6395 | Fred Sammons, Inc. | 1976-09-08 | 47 | 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