Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cederroth, Inc. USA — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
50 daysmedian FDA review time
164 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K880788 | NON ADHERENT PAD | Cederroth, Inc. USA | 1988-04-01 | 35 | 0 |
| K823057 | MEDICATED ADHESIVE STRIP | Cederroth, Inc. USA | 1983-03-31 | 164 | 0 |
| K830330 | SAVETT ALCOHOL PREP | Cederroth, Inc. USA | 1983-03-17 | 44 | 0 |
| K820059 | RESUSCITATION MASK | Cederroth, Inc. USA | 1982-03-26 | 74 | 0 |
| K813365 | MULTIPLE BANDAGE OR DRESSING | Cederroth, Inc. USA | 1982-02-04 | 66 | 0 |
| K813364 | MEDICAL TAPE (MULTIPLE) | Cederroth, Inc. USA | 1982-01-19 | 50 | 0 |
| K813361 | ADHESIVE STRIP(MULTIPLE) | Cederroth, Inc. USA | 1982-01-18 | 49 | 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