Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Scottcare Corporation — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K142180 | TELESENSE | Scottcare Corporation | 2014-12-12 | 126 | 0 |
| K092947 | TELESENTRY, MODEL TS01 | Scottcare Corporation | 2010-02-26 | 155 | 1 |
| K083382 | CHROMA, MODEL: RZ153C | Scottcare Corporation | 2009-08-13 | 272 | 0 |
| K081359 | GENESIS ECP | Scottcare Corporation | 2008-05-29 | 14 | 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