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

Vidamed, Inc. — Predicate Candidate Screening

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

79 daysmedian FDA review time
179 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K014224PRECISION PLUS TUNA OFFICE SYSTEMVidamed, Inc.2002-01-23280
K012587RF GENERATORS, DISPOSABLE CARTRIDGE KIT, DISPOSABLE CARTRIDGVidamed, Inc.2001-12-111230
K011787PRECISION TUNA OFFICE SYSTEM WITH NO RECTAL TEMPERATURE MONIVidamed, Inc.2001-07-06280
K002583TUNA (TRANS URETHRA NEEDLE) OFFICE SYSTEMVidamed, Inc.2001-02-131790
K973366COBRA HAND PIECEVidamed, Inc.1997-11-26790
K965199TUNA 5 CATHETERVidamed, Inc.1997-04-301250
K965061VIDAMED MODEDL 7600 RF GENERATORVidamed, Inc.1997-01-28410
K963180VIDAMED RF GENERATOR DATA RECORDERVidamed, Inc.1996-10-10570
K960918VIDAMED TUNA (TRANSURETHRAL NEEDLE ABLATION) SYSTEMVidamed, Inc.1996-10-082160
K955035VIDAMED SERIES 7205 ELECTROSURGICAL GENERATORVidamed, Inc.1995-11-29270
K951245VIDAMED 50 ELECTROSURGICAL GENERATOR, VIDAMED AEC (ADJUSTABLVidamed, Inc.1995-06-09840

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