Atlas FDA

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

Medelec Intl. Corp. — Predicate Candidate Screening

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

56 daysmedian FDA review time
282 days90th percentile
15clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K961013DISPOSABLE NEEDLE ELECTRODEMedelec Intl. Corp.1996-12-202820
K935017TD50 ELECTROMYOGRAPHMedelec Intl. Corp.1994-07-282820
K922548MEDELEC 2110 AND 2114 EEGMedelec Intl. Corp.1992-11-031550
K920127ELECTROENCEPHALOGRAPH RECORDING SYSTEMMedelec Intl. Corp.1992-06-101520
K912775SAPPHIRE 4ME EMG/EP SYSTEMMedelec Intl. Corp.1991-11-081370
K865106PROPHYLACTIC (CONDOM) MR. JOHNNYMedelec Intl. Corp.1987-05-201400
K863491BLOOD SPECIMEN COLLECTION DEVICESMedelec Intl. Corp.1986-10-24460
K854622PROPHYLACTIC (CONDOM)Medelec Intl. Corp.1986-04-111440
K854562CONNECTOR, BLOOD TUBING, INFUSION T. INTRAVENOUS IMedelec Intl. Corp.1986-01-09560
K854857SCALPEL, ONE-PIECE, DISPOSABLEMedelec Intl. Corp.1985-12-24190
K854859BLADES, SCALPEL STAINLESS STEELMedelec Intl. Corp.1985-12-24190
K854858SCALPEL HANDLEMedelec Intl. Corp.1985-12-24190
K854860BLADES, SCALPEL CARBON STEETMedelec Intl. Corp.1985-12-24190
K854563DISPOSABLE SYRINGES & NEEDLESMedelec Intl. Corp.1985-12-09250
K854561BLADE, SCALPELMedelec Intl. Corp.1985-12-02180

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