Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Quality Synthetics Intl, Inc. · 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) |
|---|---|---|---|---|---|
| K896623 | SAFECON CONDOMS - PINK COLOR | Quality Synthetics Intl, Inc. | 1990-02-16 | 87 | 0 |
| K884454 | SAFECON CONDOMS - RIBBED | Quality Synthetics Intl, Inc. | 1989-04-25 | 183 | 0 |
| K883524 | SAFECON CONDOMS W/SPERMICIDAL LUBRICANT | Quality Synthetics Intl, Inc. | 1989-03-29 | 224 | 0 |
| K874399 | SAFECON CONDOMS | Quality Synthetics Intl, Inc. | 1988-04-06 | 161 | 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