Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Mayer Laboratories — Predicate Candidate Screening

17 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

157 daysmedian FDA review time
476 days90th percentile
17clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K252158Sagami Original 002 Polyurethane Male CondomMayer Laboratories2026-03-302640
K001974EZ-ON CONDOMMayer Laboratories2001-10-244820
K946374KIMONO MICROTHINMayer Laboratories1995-11-083290
K946376MAXXMayer Laboratories1995-09-222820
K943064KIMONO (CONDOMS)Mayer Laboratories1995-09-224760
K925869SHEATHES, STERILE SHEATHESMayer Laboratories1994-01-064130
K926049DIGITEX, DIGITEX HYPOALLERGENICMayer Laboratories1993-07-222330
K904375KIMONO PLUSMayer Laboratories1990-11-26620
K904453LABELLING MODIFICATION TO MAXX PLUSMayer Laboratories1990-11-23570
K904840ORION PLUS/MODIFICATIONMayer Laboratories1990-11-20270
K895530STANDARD CONDOMMayer Laboratories1989-11-28760
K884469ORION PLUS W/NONOXYNOL-9 OTHERS (MULTIPLE) CONDOMSMayer Laboratories1989-03-311570
K884468SUPER MAXX OTHERS (MULTIPLE) CONDOMSMayer Laboratories1989-03-311570
K884470KIMONO PLUS OTHERS (MULTIPLE) CONDOMSMayer Laboratories1989-03-311570
K872356CONDOMS (HOMBRE BLACK/BLACK SATIN/XT-12/ORION)Mayer Laboratories1988-04-062930
K874851XL-4 PAGODA (CONDOMS)Mayer Laboratories1988-01-21570
K872799KIMONO (CONDOMS)Mayer Laboratories1987-12-081460

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