Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Bovie Medical Corporation · Predicate Candidate Screening

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

76 daysmedian FDA review time
176 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K183610Renuvion/J-Plasma Precise Handpiece, Renuvion/J-Plasma PreciBovie Medical Corporation2019-03-12760
K170777Bovie J-Plasma Precise FLEX HandpieceBovie Medical Corporation2017-05-01470
K170188Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2Bovie Medical Corporation2017-03-08440
K161558Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and NBovie Medical Corporation2016-07-29530
K161134Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941 EBovie Medical Corporation2016-06-20590
K152777Bovie Disposable Bipolar AblatorBovie Medical Corporation2016-01-151120
K152570Bovie J-Plasma Precise 360 HandpieceBovie Medical Corporation2015-11-02540
K151325Bovie J-Plasma HandpieceBovie Medical Corporation2015-08-04780
K142975Bovie Ultimate High Frequency Electrosurgical GeneratorBovie Medical Corporation2014-12-12590
K134054BOVIE IDS-310 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, AAROBovie Medical Corporation2014-03-17760
K121441CAUTERY; LOW TEMPERATURE (FINEADJUSTABLE FINE TIP, ELONGATEDBovie Medical Corporation2012-07-20660
K112233BOVIE J-PLASMA HANDPIECE WITH RETRACTABLE CUTTING BLADEBovie Medical Corporation2012-01-271760
K092383BOVIE ICON VS GENERAL PURPOSE RF GENERATOR, MODEL: VS300Bovie Medical Corporation2010-03-102170
K093025BOVIE RESISTICK II COATED ELECTROSURGICAL ELECTRODESBovie Medical Corporation2009-12-22840

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