Atlas FDA

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

Pain Management Technologies — Predicate Candidate Screening

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

90 daysmedian FDA review time
240 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K120054ULTIMA NEOPain Management Technologies2012-06-051510
K083494ULTIMA FIVEPain Management Technologies2009-01-06420
K073386JOINT STIM, MODEL 1000Pain Management Technologies2008-07-302400
K030375SOFT-TOUCH TENS ELECTRODEPain Management Technologies2003-05-05900
K011411SELF-ADHESIVE ELECTRODESPain Management Technologies2001-06-13360

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