Atlas FDA

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

Cis-Us, Inc. — Predicate Candidate Screening

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

84 daysmedian FDA review time
304 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K951708ELSA-HCTCis-Us, Inc.1995-09-051450
K950211ELSA-PTHCis-Us, Inc.1995-04-13840
K890799CURIETRON 192 HIGH DOSE RATECis-Us, Inc.1989-10-272520
K882449CESIUM 137 SOURCE, MODEL CSM-40Cis-Us, Inc.1989-04-143040
K871502PERSONNEL PROTECTIVE SHIELDCis-Us, Inc.1987-05-08210
K865027IRRADIATOR FOR BIOLOGICAL MATERIALS, IBL-137CCis-Us, Inc.1987-02-26650
K863778VENTICIS IICis-Us, Inc.1986-10-27310
K860823ELSA-PROL IMMUNORADIOMETRIC ASSAY KITCis-Us, Inc.1986-08-191680
K860824TSHK-NN RIA KITCis-Us, Inc.1986-04-28550

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