Atlas FDA

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

Stimwave Technologies Incorporated — Predicate Candidate Screening

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

136 daysmedian FDA review time
182 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K182720Freedom Spinal Cord Stimulator (SCS) SystemStimwave Technologies Incorporated2019-03-291820
K180981Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable AssemblyStimwave Technologies Incorporated2018-09-191590
K172644Sandshark Injectable Anchor Kit, Injectroducer Handle, LoadiStimwave Technologies Incorporated2017-11-03630
K170141Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision KiStimwave Technologies Incorporated2017-05-021050
K162161Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision KiStimwave Technologies Incorporated2016-12-161360
K160600Freedom Spinal Cord Stimulator SystemStimwave Technologies Incorporated2016-08-261770
K150517Freedom Spinal Cord Stimulator SystemStimwave Technologies Incorporated2015-06-05950
K141399FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEMStimwave Technologies Incorporated2014-10-101350

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