Atlas FDA

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

Monitor Science Corp. — Predicate Candidate Screening

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

66 daysmedian FDA review time
76 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K790580RIA KIT, PROSTATIC ACIDMonitor Science Corp.1979-05-25590
K780950BIO-MONITOR TOBRAMYCINMonitor Science Corp.1978-08-14660
K780949BIO-MONITOR AMIKACINMonitor Science Corp.1978-08-14660
K780951BIO-MONITOR GENTAMICINMonitor Science Corp.1978-08-14660
K772038KANAMYCIN RIAMonitor Science Corp.1978-01-12760
K772039BETA-HCG RIAMonitor Science Corp.1977-11-23260

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