Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
ISB · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
21 daysmedian FDA review time
119 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K842805 | IMPULS 3, IT SELECTOR | Robert Bosch Corp. | 1984-08-01 | 15 | 0 |
| K842262 | PIRD-Y | Pirdy, Inc. | 1984-06-28 | 21 | 0 |
| K790949 | GALVANIC UNIT | Rami International Corp. | 1979-08-16 | 87 | 0 |
| K780632 | MAXICEPTOR | Med General | 1978-08-14 | 119 | 0 |
| K780730 | FIGURETRIM | Jay-Mar INternational Enterprises, IN | 1978-05-09 | 7 | 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