Atlas FDA

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

Biowave Corporation · Predicate Candidate Screening

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

112 daysmedian FDA review time
259 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K261522BioWave BioWrapsBiowave Corporation2026-06-03270
K203158BioWave BioWrapsBiowave Corporation2021-07-082590
K210202BioWaveGO RXBiowave Corporation2021-02-24300
K180943BioWaveGOBiowave Corporation2018-08-171290
K152437BiowaveHOME Neuromodulation Pain Therapy DeviceBiowave Corporation2015-09-25290
K072123HOMEWAVE NEUROMODULATIONS PAIN THERAPY DEVICEBiowave Corporation2008-02-011830
K061166DEEPWAVE PERCUTANEOUS NEUROMODULATION PAIN THERAPY SYSTEMBiowave Corporation2006-08-151100
K052289DEEPWAVE NEUROMODULATION PAIN THERAPY DEVICEBiowave Corporation2005-12-131120

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