Atlas FDA

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

Clinicon Corp. — Predicate Candidate Screening

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

84 daysmedian FDA review time
287 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K121580SURELASE CO2 LASER SYSTEMClinicon Corp.2012-09-251180
K063698CO2 LASER SYSTEM, MODEL C-LASClinicon Corp.2007-03-02790
K014236CLINICON WAVEGUIDE PLATFORM WITH INTERCONNECT FOR LUXAR ACCEClinicon Corp.2002-03-26900
K014048CLINICON UNIVERSAL WAVEGUIDE HANDPIECE AND FIBER TIPSClinicon Corp.2002-02-11660
K992472SUREGUIDE CO2 LASER BEAM DELIVERY SYSTEMClinicon Corp.1999-09-08440
K983463SURECAUT DIAMOND LASER KNIFEClinicon Corp.1998-12-11710
K970143C4Clinicon Corp.1997-10-292870
K964831SURESCANClinicon Corp.1997-08-082490
K962242SURESCANClinicon Corp.1996-09-03840

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