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

Staodyne, Inc. — Predicate Candidate Screening

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

122 daysmedian FDA review time
408 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K952680VARAPULSE-2Staodyne, Inc.1995-12-041750
K941923STERILE TREATMENT ELECTRODEStaodyne, Inc.1995-06-024080
K931925TPK CUTANEOUS ELECTRODEStaodyne, Inc.1993-08-161220
K926510STAODYN EMS+2Staodyne, Inc.1993-08-112240
K931424MAXIMA IStaodyne, Inc.1993-06-04740
K930865STAODYN MAXIMA IIIStaodyne, Inc.1993-05-13840
K925898MODEL 19 STIMULATOR, NERVE, TRANSCUTANEOUSStaodyne, Inc.1993-01-28690
K921110TENSStaodyne, Inc.1992-08-141580
K921668STAODYN TUWAVEStaodyne, Inc.1992-08-031170

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