Mayer Laboratories
Berkeley, CA, US
MAYER LABORATORIES appears in FDA device records in Berkeley, CA. FDA records list 20 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 20 510(k) clearances for Mayer Laboratories between 1987 and 2026. The busiest year on record is 1989, with 4. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1987 | 1 |
| 1988 | 2 |
| 1989 | 4 |
| 1990 | 3 |
| 1993 | 1 |
| 1994 | 1 |
| 1995 | 3 |
| 2001 | 1 |
| 2011 | 1 |
| 2012 | 1 |
| 2013 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252158 | Sagami Original 002 Polyurethane Male Condom | MOL | Substantially Equivalent | |
| K130345 | AQUA LUBE NATURAL LUBRICANT - REGULAR, WARMING | NUC | Substantially Equivalent | |
| K113686 | KIMONO MICROTHIN WITH AQUA LUBE, REALITY ULTRA LUBRICATED | HIS | Substantially Equivalent | |
| K110325 | AQUA LUBE | NUC | Substantially Equivalent | |
| K001974 | EZ-ON CONDOM | MOL | Substantially Equivalent | |
| K946374 | KIMONO MICROTHIN | HIS | Substantially Equivalent | |
| K946376 | MAXX | HIS | Substantially Equivalent | |
| K943064 | KIMONO (CONDOMS) | HIS | Substantially Equivalent | |
| K925869 | SHEATHES, STERILE SHEATHES | ITX | Substantially Equivalent | |
| K926049 | DIGITEX, DIGITEX HYPOALLERGENIC | LYY | Substantially Equivalent | |
| K904375 | KIMONO PLUS | HIS | Substantially Equivalent | |
| K904453 | LABELLING MODIFICATION TO MAXX PLUS | HIS | Substantially Equivalent | |
| K904840 | ORION PLUS/MODIFICATION | HIS | Substantially Equivalent | |
| K895530 | STANDARD CONDOM | HIS | Substantially Equivalent | |
| K884470 | KIMONO PLUS OTHERS (MULTIPLE) CONDOMS | HIS | Substantially Equivalent | |
| K884469 | ORION PLUS W/NONOXYNOL-9 OTHERS (MULTIPLE) CONDOMS | HIS | Substantially Equivalent | |
| K884468 | SUPER MAXX OTHERS (MULTIPLE) CONDOMS | HIS | Substantially Equivalent | |
| K872356 | CONDOMS (HOMBRE BLACK/BLACK SATIN/XT-12/ORION) | HIS | Substantially Equivalent | |
| K874851 | XL-4 PAGODA (CONDOMS) | HIS | Substantially Equivalent | |
| K872799 | KIMONO (CONDOMS) | HIS | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2938651 | 2938651 | MAYER LABORATORIES | 1400 Shattuck Ave., Suite 9, Berkeley, CA 94709 US | 2026 | and 3 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- HISCondom
- MOLCondom, Synthetic
- EXJDevice, Incontinence, Urosheath Type, Sterile
- LYYLatex Patient Examination Glove
- KMJLubricant, Patient
- NUCLubricant, Personal
- NURPad, Menstrual, Intralabial
- LZAPolymer Patient Examination Glove
- MBUSingle-Use Internal Condom
- HILTampon, Menstrual, Scented, Scented-Deodorized
- HEBTampon, Menstrual, Unscented
- ITXTransducer, Ultrasonic, Diagnostic
- LYZVinyl Patient Examination Glove
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain