Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Schmid Laboratories, Inc. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
113 daysmedian FDA review time
198 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K897140 | THIN CONDOM RAMSES & SHEIK | Schmid Laboratories, Inc. | 1990-07-13 | 198 | 0 |
| K900679 | MINT SCENTED CONDOMS | Schmid Laboratories, Inc. | 1990-06-07 | 115 | 0 |
| K884399 | STANDARD LATEX CONDOM | Schmid Laboratories, Inc. | 1989-03-01 | 133 | 0 |
| K882893 | CONDOMS (RAMSES, SHEIK AND KOROMEX) | Schmid Laboratories, Inc. | 1988-10-26 | 107 | 0 |
| K880820 | OKAMOTO CONDOMS SPERMICIDALLY LUBRICATED | Schmid Laboratories, Inc. | 1988-06-21 | 112 | 0 |
| K874791 | CONDOMS (RAMSES EXTRA, SHEIK ELITE AND KOROMEX) | Schmid Laboratories, Inc. | 1988-04-12 | 141 | 0 |
| K880202 | OKAMOTO CONDOMS | Schmid Laboratories, Inc. | 1988-02-26 | 38 | 0 |
| K874718 | STANDARD LATEX CONDOMS (RAMSES, SHEIK AND KOROMEX) | Schmid Laboratories, Inc. | 1987-12-08 | 21 | 0 |
| K822088 | MALE CONDOM | Schmid Laboratories, Inc. | 1982-11-03 | 113 | 0 |
| K802354 | PROPHYLACTIC W/SPERMICIDAL LUBRICANT | Schmid Laboratories, Inc. | 1980-09-25 | 0 | 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