Atlas FDA

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

Stimulation Technology, Inc. — Predicate Candidate Screening

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

27 daysmedian FDA review time
28 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K791048STIMTECH NEUROMUSCULAR STIMULATOR, C 600Stimulation Technology, Inc.1979-07-03270
K790345STIMTECH TENS ELECTRODEStimulation Technology, Inc.1979-03-21280
K781565ELECTRICAL NERVE STIMULATOR MODEL 6035Stimulation Technology, Inc.1978-10-11280
K772224NERVE STIMULATOR, ELEC. TRANSCUTANEOUSStimulation Technology, Inc.1977-12-15100
K770448INS - T.E.N.S.Stimulation Technology, Inc.1977-03-1570
K770447EPC INSTICKSStimulation Technology, Inc.1977-03-1570

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