Atlas FDA

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

Santa Barbara Medco, Inc. — Predicate Candidate Screening

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

41 daysmedian FDA review time
90 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K850492NASAL SEPTAL BUTTONSanta Barbara Medco, Inc.1985-03-07270
K842483SANTA BARBARA MEDCO-LANTOPHORETIC APPLICSanta Barbara Medco, Inc.1984-08-31670
K823921PHYSICIANS CHOICE SILICONE EAR PUTTYSanta Barbara Medco, Inc.1983-03-28900
K821187MEDCO CUSTOM EAR PROTECTOR MOLD KITSanta Barbara Medco, Inc.1982-05-27300
K812069BORES* DEPTH GAUGESanta Barbara Medco, Inc.1981-08-31410
K812071RK IV SURGICAL BLADESSanta Barbara Medco, Inc.1981-08-31410
K812070BORES* ADJUSTABLE BLADE HOLDERSanta Barbara Medco, Inc.1981-08-18280
K802638OTOLOGICAL VENTILATION TUBESSanta Barbara Medco, Inc.1980-11-12210

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