Atlas FDA

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

Mecron Medical Products, Inc. · Predicate Candidate Screening

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

92 daysmedian FDA review time
162 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K861138MASH DERMATOMEMecron Medical Products, Inc.1986-04-14190
K854191MECRON UNCEMENTED STRUCTURED STEM HIPMecron Medical Products, Inc.1985-11-13930
K844775EFFNER-EYE CAUTERY WITH BATTERY HANDLEMecron Medical Products, Inc.1985-08-122450
K844774EFFNER FIBER OPTIC CABLES FOR COLD LIGHT TRANSMISSMecron Medical Products, Inc.1985-04-221330
K844488MECRON CEMENTED STRUCTURED STEM HIP PROSTHESISMecron Medical Products, Inc.1985-03-121130
K844487MECRON FEMORAL HEAD W/CONE AS UNIPOLAR OR BIPOLARMecron Medical Products, Inc.1985-02-19920
K844486MECRON MRC-HEADLESS FEMORAL COMPONENTMecron Medical Products, Inc.1985-02-19920
K844773EFF-EFFNER BULBSMecron Medical Products, Inc.1985-01-08290
K843449AUTODYNAMIC COMPRESSION HIP SCREW-PLATEMecron Medical Products, Inc.1984-10-22470
K843554BONE SCREWSMecron Medical Products, Inc.1984-10-01210
K843553BONE PLATESMecron Medical Products, Inc.1984-10-01210
K840271CEMENTLESS HIP PROSTHESISMecron Medical Products, Inc.1984-07-031620
K834499SHEATHS FOR REINFORCING BONE CEMENTMecron Medical Products, Inc.1984-04-241260
K833881ACETABULAR SCREW RINGMecron Medical Products, Inc.1984-01-13650

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