Atlas FDA

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

Lhasa Oms, Inc. — Predicate Candidate Screening

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

308 daysmedian FDA review time
429 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K200636AXUS ES-5 Electro-Acupuncture DeviceLhasa Oms, Inc.2021-02-033300
K062003NEURO WAVE 6Lhasa Oms, Inc.2007-09-194290
K060508POINTER PLUSLhasa Oms, Inc.2006-06-191120
K060517POINTER EXCELLhasa Oms, Inc.2006-06-191120
K061080IR PRO 250Lhasa Oms, Inc.2006-06-14570
K050989AWQ-104Lhasa Oms, Inc.2006-04-063520
K051020ES-160Lhasa Oms, Inc.2006-02-243080
K050435E-STIM IILhasa Oms, Inc.2005-09-061960

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