Atlas FDA

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

Sicel Technologies, Inc. — Predicate Candidate Screening

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

34 daysmedian FDA review time
242 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K083035DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEMSicel Technologies, Inc.2008-11-13300
K081859MODIFICATION TO ONEDOSE PATIENT DOSIMETRY SYSTEMSicel Technologies, Inc.2008-08-04340
K080004DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEMSicel Technologies, Inc.2008-01-23210
K071399DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODEL DVSSicel Technologies, Inc.2007-06-20300
K061051DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODELS DVSicel Technologies, Inc.2006-06-13570
K052118DOSE VERIFICATION SYSTEMSicel Technologies, Inc.2006-04-032420
K040687ONEDOSE PATIENT DOSIMETRY SYSTEMSicel Technologies, Inc.2004-06-251010

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