Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Ttk Healthcare Limited · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K230049 | SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belg | Ttk Healthcare Limited | 2023-09-07 | 244 | 0 |
| K213547 | SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth | Ttk Healthcare Limited | 2021-12-23 | 45 | 0 |
| K202403 | SKORE (Colors & Flavors), SKORE (Colors) | Ttk Healthcare Limited | 2021-04-15 | 237 | 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