Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Suretex Prophylactics (India) , Ltd. · 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) |
|---|---|---|---|---|---|
| K992081 | VARIOUS ANSELL TRADENAMES OR PRIVATE LABEL | Suretex Prophylactics (India) , Ltd. | 1999-08-19 | 59 | 0 |
| K983320 | ROYALE BRAND LATEX CONDOMS SILICONE LUBRICANT COLORED-OR ASS | Suretex Prophylactics (India) , Ltd. | 1998-12-11 | 81 | 1 |
| K981621 | ROYALE OF LATEX CONDOMS - SPERMICIDAL LUBRICANT - COLORED OR | Suretex Prophylactics (India) , Ltd. | 1998-06-19 | 44 | 1 |
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