Atlas FDA

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

Biolitec Medical Devices, Inc. · Predicate Candidate Screening

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

37 daysmedian FDA review time
90 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K120231EVOLVE HPD 980/ 1470NM MULTIWAVELENGTH DIODE LASER (EVOLVE DBiolitec Medical Devices, Inc.2012-04-24900
K113688MEGABEAM REUSABLE FIBER OPTIC DELIVERY SYSTEMBiolitec Medical Devices, Inc.2012-03-13890
K113858MEGABEAM ENDO-ENT PROBEBiolitec Medical Devices, Inc.2012-01-24250
K113709MEGABEAM FIBER OPTIC DELIVERY SYSTEM WITH ADDITIONAL TIPS & Biolitec Medical Devices, Inc.2012-01-20320
K113792MEGABEAM ENDOCULAR PROBE AND ASPIRATING ENDOCULAR PROBEBiolitec Medical Devices, Inc.2012-01-19270
K112987TWISTER SIDE FIRE OPTICAL FIBER DELIVERY SYSTEMBiolitec Medical Devices, Inc.2011-12-16710
K112299ENDOVASCULAR LASER VEIN SYSTEM KITBiolitec Medical Devices, Inc.2011-11-03850
K112442RADIAL-EMITTING SHAPED FIBER OPTIC DELIVERY SYSTEMBiolitec Medical Devices, Inc.2011-09-30370
K112324CERALAS 980NM DIODE LASER FAMILYBiolitec Medical Devices, Inc.2011-09-06250

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