Schmid Laboratories, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Schmid Laboratories, Inc.” (first 1980, latest 1990), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 112 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HIS | Condom | 9 | 9 |
Plus 1 more product codes.
Review panels
Most recent Schmid Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K897140 | THIN CONDOM RAMSES & SHEIK | HIS | 1990-07-13 | 198 |
| K900679 | MINT SCENTED CONDOMS | HIS | 1990-06-07 | 115 |
| K884399 | STANDARD LATEX CONDOM | HIS | 1989-03-01 | 133 |
| K882893 | CONDOMS (RAMSES, SHEIK AND KOROMEX) | HIS | 1988-10-26 | 107 |
| K880820 | OKAMOTO CONDOMS SPERMICIDALLY LUBRICATED | HIS | 1988-06-21 | 112 |
| K874791 | CONDOMS (RAMSES EXTRA, SHEIK ELITE AND KOROMEX) | HIS | 1988-04-12 | 141 |
| K880202 | OKAMOTO CONDOMS | HIS | 1988-02-26 | 38 |
| K874718 | STANDARD LATEX CONDOMS (RAMSES, SHEIK AND KOROMEX) | HIS | 1987-12-08 | 21 |
| K822088 | MALE CONDOM | HIS | 1982-11-03 | 113 |
| K802354 | PROPHYLACTIC W/SPERMICIDAL LUBRICANT | — | 1980-09-25 | 0 |
Recalls
openFDA lists no recalls under a recalling firm named Schmid Laboratories, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Schmid Laboratories, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Schmid Laboratories, Inc.” (first 1980, latest 1990), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Schmid Laboratories, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Schmid Laboratories, Inc. is 112 days.
Which FDA product codes appear under Schmid Laboratories, Inc.?
The most frequent FDA product codes under this applicant name are HIS (Condom, 9).
Next steps
- See all 10 Schmid Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HIS, Schmid Laboratories, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.