Atlas FDA

Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

LRX — Predicate Candidate Screening

82 FDA 510(k) clearances under this product code; the 50 most recent screened below.

76 daysmedian FDA review time
245 days90th percentile
82clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K252175LANDR Contact LENS CaseFourth Axis, LLC2026-02-102140
K250495MINI VP1 (PL67_F); MINI VP1 (PL61_F)Avizor S.A.2025-08-011620
K240095CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4Shanghai Care US Medical Product Co., Ltd.2024-10-092710
K231123Phoenix Contact Lens Case - dome top flat pack (CL-01); PhoePhoenix Innovative Healthcare Manufacturers Pvt. , Ltd.2023-08-301320
K173538Clear Care Cleaning & Disinfecting Solution, AOCup Lens CaseAlcon Laboratories, Inc.2017-12-04190
K172925Contact Lens Case, Model: A-1, B-1P L Overseas Limited2017-11-30660
K173365Bausch + Lomb Boston Scleral Lens CaseBausch & Lomb, Incorporated2017-11-17220
K171539Contact Lens CaseE-Link Plastic & Metal Industrial Co.,Ltd2017-07-14490
K171163Contact Lens Case Round GlassesFiftytwoways, Ltd.2017-06-27680
K162869Contact Lens CaseNingbo Yinzhou Zonghai Artware Co., Ltd.2016-12-09570
K160005Contact Lens Case (multiple brand name)Danyang Chanxin Glasses Cases Factory2016-06-071550
K142717Cat Contact Lens Case, Sunglasses Contact Lens Case, 1st ConNi Hau Industrial Co., Ltd.2015-05-072260
K143351iCase Contact Lens CaseNovabay Pharmaceuticals, Inc.2015-04-291560
K140488CONTACT LENS CASEMaca Plastics, Inc.2014-09-101950
K131783POLAROID CONTACTSPODViopti, Ltd.2014-02-212490
K130930OWL CONTACT LENS CASES, DOG CONTACT LENS CASESNingbo Lishunda Electronics Co., Ltd.2014-02-123140
K131875MENICON NECT CONTACT LENS CASEForesight Regulatory Strategies2013-08-06430
K130753STANDARD CONTACT LENS CASE; FLIP N SLIDE CONTACT LENS CASEWatchdog Group, LC2013-06-13860
K122700PROSBEN CONTACT LENS CASES MODEL CA66-02, CA66-03WB, CA66-04Prosben, Inc.2013-05-312690
K130285PROGENT LARGE DIAMETER CONTACT LENS CASE FOR RIGID GAS PERMEThe Lagado Corp.2013-04-03570
K120904POLARIS DIAL-A-DATE CONTACT LENS CASEReliance Design & Manufacture Corp.2012-11-262450
K120969AC LENS BRANDED CONTACT LENS CASEArlington Contact Lens Services,Inc.2012-07-111030
K121030SACKS HOLDINGS INC.'S CONTACT LENS STORAGE CASESacks Holdings, Inc.2012-07-06920
K112832EYE CARE CURE CONTACT LENS CASEEye Care and Cure2011-12-05670
K111856SOFT GRIP CONTACT LENS CASE, DELUXE CONTACT LENS CASE, ECONOApothecary Products, Inc.2011-07-14150
K093377POLARIS CONTACT LENS CASEReliance Design & Manufacturing Corp.2010-04-271800
K090362IMAG, IPOD, EZ-FIND AND ISLIDEVoguestrap2009-02-27140
K071081CONTACT LENS CASENingbo Kaida Rubber and Plastic Technology Co., LT2007-05-01140
K052809SAUFLON FLAT COLOURED LENS CASESauflon Pharmaceuticals, Ltd.2005-11-02290
K041820SOLO-CARE AQUA ANTIMICROBIAL LENS CASECiba Vision Corporation2005-09-094300
K042578I-PROMOTIONS CONTACT LENS CASEI-Promotions, Inc.2005-01-251250
K040914POLYVIAL/POLYPAK, CONTACT LENS CASE AND STORAGE SYSTEM CONTAExero Products, Inc.2004-05-27490
K033656SAUFLON FLAT LENS CASE/SAUFLON 2003 BARREL LENS CASESauflon Pharmaceuticals, Ltd.2004-02-02730
K032309NOVELENS CONTACT LENS CLEANING ENHANCEMENT AND STORAGE ACCESNovelens, Inc.2003-12-041320
K030987CONTACT LENS STORAGE CASEPelican Products2003-06-12760
K021248ICASEIkeeps, Inc.2002-09-241580
K013232CYBERCASES BY BAUSCH & LOMBBausch & Lomb, Inc.2001-11-20540
K991206BONASSE CONTACT LENS CASEBonasse Ent. Co., Ltd.2000-06-064240
K993487PARAGON LENS VIALParagon Vision Sciences1999-12-22680
K993486PARAGON LENS CARRIERParagon Vision Sciences1999-12-22680
K974635PARAGON LENS CAREParagon Vision Sciences1998-02-04540
K974281ALCON CONTACT LENS CASEAlcon Laboratories1998-01-20670
K971618ALCON CONTACT LENS CASEAlcon Laboratories1997-07-14730
K962512BOSTON CONTACT LENS CASEPolymer Technology Div. Wilmington Partners, L.P.1996-07-12150
K950869JC960 2 IN 1 EYEGLASS/CONTACT LENS CASEJobar Intl., Inc.1995-10-272420
K951552BOSTON CONTACT LENS CASEPolymer Technology Corp.1995-06-26830
K951182RYDER CONTACT LENS CASE MODEL 10670Bradstreet Clinical Research Assoc., Inc.1995-05-16610
K951181RYDER CONTACT LENS CASEBradstreet Clinical Research Assoc., Inc.1995-05-12570
K950878MENICON SP VIALHyman, Phelps & McNamara, P.C.1995-04-07380
K950530PRO-TEC-CASEHyman, Phelps & McNamara, P.C.1995-04-07590

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