Atlas FDA

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

Med General — Predicate Candidate Screening

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

21 daysmedian FDA review time
106 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K791097CEPTORTRODE WITH CEPTOR HESIVEMed General1979-08-03520
K791098SINGLE-USE MINI-BULLDOGMed General1979-06-22100
K790763MAXI-VAC TMMed General1979-04-2350
K790269CEPTOR HESIVEMed General1979-02-26210
K782006MEDGENERAL SINGLE-USE BULLDOGMed General1978-12-15140
K781239MYO-STIMMed General1978-11-031060
K780632MAXICEPTORMed General1978-08-141190
K780698STIMULATORS, NERVE, ELECTRICALMed General1978-05-12160
K780117CARDIOMETERMed General1978-02-03110
K771702VESSEL-STABILIZERMed General1977-12-13960
K771701VESSEL-CLUDEMed General1977-12-13960
K771765MYO-CHECKMed General1977-09-30110

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