Mayer Laboratories: FDA filings under this applicant name
FDA lists 20 510(k) clearances under the applicant name “Mayer Laboratories” (first 1987, latest 2026), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 164 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 | 1 | 82 |
| 2013 | 1 | 171 |
| 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 | 1 | 264 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Mayer Laboratories took a median 264 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 140 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HIS | Condom | 14 | 14 |
| MOL | Condom, Synthetic | 2 | 2 |
| NUC | Lubricant, Personal | 2 | 2 |
| ITX | Transducer, Ultrasonic, Diagnostic | 1 | 1 |
| LYY | Latex Patient Examination Glove | 1 | 1 |
Review panels
- Obstetrics and Gynecology (18)
- General Hospital (1)
- Radiology (1)
Most recent Mayer Laboratories 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252158 | Sagami Original 002 Polyurethane Male Condom | MOL | 2026-03-30 | 264 |
| K130345 | AQUA LUBE NATURAL LUBRICANT - REGULAR, WARMING | NUC | 2013-08-01 | 171 |
| K113686 | KIMONO MICROTHIN WITH AQUA LUBE, REALITY ULTRA LUBRICATED | HIS | 2012-03-06 | 82 |
| K110325 | AQUA LUBE | NUC | 2011-12-08 | 308 |
| K001974 | EZ-ON CONDOM | MOL | 2001-10-24 | 482 |
| K946374 | KIMONO MICROTHIN | HIS | 1995-11-08 | 329 |
| K946376 | MAXX | HIS | 1995-09-22 | 282 |
| K943064 | KIMONO (CONDOMS) | HIS | 1995-09-22 | 476 |
| K925869 | SHEATHES, STERILE SHEATHES | ITX | 1994-01-06 | 413 |
| K926049 | DIGITEX, DIGITEX HYPOALLERGENIC | LYY | 1993-07-22 | 233 |
10 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Mayer Laboratories.
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 Mayer Laboratories?
FDA lists 20 510(k) clearances under the applicant name “Mayer Laboratories” (first 1987, latest 2026), across 5 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Mayer Laboratories?
The median time from FDA receipt to decision across 510(k)s cleared under the name Mayer Laboratories is 164 days.
Which FDA product codes appear under Mayer Laboratories?
The most frequent FDA product codes under this applicant name are HIS (Condom, 14); MOL (Condom, Synthetic, 2); NUC (Lubricant, Personal, 2).
Next steps
- See all 20 Mayer Laboratories clearances with predicates and recalls
- Run predicate analysis for product code HIS, Mayer Laboratories'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.