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Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

The Montana Deaconess Medical Center · Predicate Candidate Screening

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

34 daysmedian FDA review time
41 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K841747MANNITOL SALT AGARThe Montana Deaconess Medical Center1984-06-07410
K841752XYLOSE-LYSINE DESOXYCHOLATE AGARThe Montana Deaconess Medical Center1984-06-07410
K841753MACCONKEY AGARThe Montana Deaconess Medical Center1984-06-07410
K841746SALMONELLA-SHIGELLA AGARThe Montana Deaconess Medical Center1984-05-31340
K841748SHEEP BLOOD AGARThe Montana Deaconess Medical Center1984-05-31340
K841749CHOCOLATE AGARThe Montana Deaconess Medical Center1984-05-31340
K841750MARTIN-LEWIS AGARThe Montana Deaconess Medical Center1984-05-31340
K841751LEVINE EOSIN METHYLENE BLUE AGARThe Montana Deaconess Medical Center1984-05-31340
K841755MUELLER-HINTON AGARThe Montana Deaconess Medical Center1984-05-14170
K841745HEKTOEN ENTERIC AGARThe Montana Deaconess Medical Center1984-05-11140
K841754COLUMBIA CNA AGARThe Montana Deaconess Medical Center1984-05-07100

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