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

Conmed Integrated Systems (Cmis) — Predicate Candidate Screening

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

35 daysmedian FDA review time
57 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K091648NURSE'S ASSISTANT O.R. CONTROL SYSTEM ,1.8Conmed Integrated Systems (Cmis)2009-08-05570
K060717NURSE ASSISTANT 1.7 O.R. CONTROL SYSTEMConmed Integrated Systems (Cmis)2006-04-25390
K052740NURSE'S ASSISTANT 1.7 O.R. CONTROL SYSTEMConmed Integrated Systems (Cmis)2005-10-17170
K050829NURSE'S ASSISTANT 1.7 O.R. CONTROL SYSTEMConmed Integrated Systems (Cmis)2005-05-06350
K031979CONMED INTEGRATED SYSTEMS NURSES ASSISTANTConmed Integrated Systems (Cmis)2003-07-25290

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