Atlas FDA

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

Paragon Vision Sciences — Predicate Candidate Screening

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

87 daysmedian FDA review time
203 days90th percentile
15clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K180172FluoroPerm 30 & Paragon Thin (paflufocon C) RGP contact lensParagon Vision Sciences2018-03-16530
K120996FLUOROPERM 30 PARAGON HDS FLUOROPERM 60 PARAGON HDS 100 FLUOParagon Vision Sciences2012-06-28870
K082799HDS HI 1.54Paragon Vision Sciences2009-01-271260
K070637FLUOROPERM 92, 60, 30 AND 151 AND PARAGON HDS, HDS 100 AND TParagon Vision Sciences2007-05-01550
K052983FLUOROPERM 151 (PAFLUFOCON D) AND PARAGON HDS 100 (PAFLUFOCOParagon Vision Sciences2006-02-101090
K013310PVS BASIC 2; EPIC 2Paragon Vision Sciences2002-04-252030
K010109FLUOROPERM 151-OK, PARAGON HDS 100-OKParagon Vision Sciences2001-02-28470
K002845PAFLUFOCON C AND E DAILY CONTACT LENSParagon Vision Sciences2000-12-08870
K993586SPORTSIGHT GPParagon Vision Sciences2000-05-222130
K000224FLUROPERM 60-OK, PARAGON HDS-OKParagon Vision Sciences2000-04-17840
K993487PARAGON LENS VIALParagon Vision Sciences1999-12-22680
K993486PARAGON LENS CARRIERParagon Vision Sciences1999-12-22680
K984436PVS BASICSParagon Vision Sciences1999-04-211280
K974635PARAGON LENS CAREParagon Vision Sciences1998-02-04540
K940277PAFLUFOCON A, B, C & DParagon Vision Sciences1994-05-091100

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