Atlas FDA

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

Medovations, Inc. — Predicate Candidate Screening

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

59 daysmedian FDA review time
223 days90th percentile
31clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K142068BULLDOG BIOPSY VALVE, OLYMPUS AND FUJINON;PENTAX COMPATIBLE;Medovations, Inc.2015-03-102230
K002363MEDOVATIONS ESOPHAGEAL DILATORMedovations, Inc.2000-11-01900
K972119MALONEY BOUGE (1210-XX)/HURST BOUGIE (1212-XX)Medovations, Inc.1998-02-022420
K924646OVER THE GUIDEWIRE DILATATION SYSTEMMedovations, Inc.1994-12-058120
K913678TROCAR CATHETERMedovations, Inc.1991-12-161190
K905478YANKAUER SUCTION DEVICEMedovations, Inc.1990-12-19130
K874309URETHAL CATHETERMedovations, Inc.1987-12-07480
K864963STOMACH EVACULATOR - EWALD STYLEMedovations, Inc.1987-10-142960
K864962OBERTO MOUTH PROPMedovations, Inc.1987-02-19590
K8649645 - IN - 1 CONNECTORMedovations, Inc.1987-01-20290
K854616ENTERAL FEEDING BAGMedovations, Inc.1986-01-23660
K851048CHEST CATHETERS/THORACIC CATHETERSMedovations, Inc.1985-06-05830
K851047PLASTIC TUBE EXTENTION SETMedovations, Inc.1985-04-25420
K833591FEEDING TUBEMedovations, Inc.1983-11-28470
K833055LARYNGOSCOPE BLADES/HANDLES & LAMPSMedovations, Inc.1983-11-14680
K833054GASTRIC SUMP TUBESMedovations, Inc.1983-10-19420
K830990BLAKEMORE TUBEMedovations, Inc.1983-06-02650
K831009CANTOR TUBEMedovations, Inc.1983-06-02640
K830998MILLER-ABBOTT TUBEMedovations, Inc.1983-06-02650
K830989BAKER JEJUNOSTOMY TUBEMedovations, Inc.1983-06-02650
K830991ESOPHAGEAL BOUGIESMedovations, Inc.1983-06-02650
K830987LEVIN TUBEMedovations, Inc.1983-05-27590
K830986RECTAL TUBESMedovations, Inc.1983-05-27590
K830985STOMACH TUBEMedovations, Inc.1983-05-27590
K831007CONNECTING TUBESMedovations, Inc.1983-05-18490
K830984OXYGEN CATHETERSMedovations, Inc.1983-05-18500
K831008HEAD STRAPMedovations, Inc.1983-05-09400
K830982MASKSMedovations, Inc.1983-05-09410
K830983AIRWAYS & NASOPHARYNGEAL TYPEMedovations, Inc.1983-05-09410
K830988OXYGEN CONNECTING TUBEMedovations, Inc.1983-05-03350
K830942SUCTION CATHETERSMedovations, Inc.1983-04-14210

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