Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
LPN — Predicate Candidate Screening
120 FDA 510(k) clearances under this product code; the 50 most recent screened below.
90 daysmedian FDA review time
241 days90th percentile
120clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K222541 | Bausch + Lomb Preservative Free Lubricating and Rewetting Dr | Bausch & Lomb, Incorporated | 2022-12-06 | 106 | 0 |
| K221263 | Aqua Naina Plus Sterile Saline Solution | Chemtex USA, Inc. | 2022-10-12 | 163 | 0 |
| K202932 | ABT12 multi-purpose solution | Bausch & Lomb, Incorporated | 2021-05-28 | 241 | 0 |
| K210051 | OTE MPS 045 Multi-purpose Lens Care Solution | Ote North America, LLC | 2021-05-26 | 138 | 0 |
| K193441 | Aqua Naina Sterile Saline Solution | Chemtex USA, Inc. | 2020-05-26 | 167 | 0 |
| K200747 | PuriLens Plus Preservative Free Saline | The Lifestyle Company, Inc. | 2020-05-15 | 53 | 0 |
| K191872 | Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solut | Menicon Co, Ltd. | 2020-03-02 | 234 | 0 |
| K190674 | REFRESH RELIEVA For CONTACTS | Allergan, Inc. | 2019-08-08 | 146 | 0 |
| K191795 | AOCup Lens Case with AODisc | Alcon Laboratories, Inc. | 2019-07-31 | 28 | 0 |
| K170483 | Bausch + Lomb Sensitive Eyes Plus Saline Solution | Bausch & Lomb, Incorporated | 2017-04-11 | 54 | 0 |
| K161819 | NNR06 Multi-Purpose Solution | Bausch & Lomb, Incorporated | 2016-11-25 | 147 | 0 |
| K162597 | Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case | Alcon Laboratories, Inc. | 2016-10-19 | 30 | 0 |
| K161622 | LensGiene Sterile Saline Solution | Optics Laboratory, Inc. | 2016-08-11 | 59 | 0 |
| K151768 | Menicon Saline Rinse Solution | Menicon Co, Ltd. | 2015-08-28 | 59 | 0 |
| K142284 | CLEAR CARE PLUS CLEANING & DISINFECTIONG SOLUTION WITH HYDRA | Alcon Laboratories, Inc. | 2015-01-26 | 161 | 1 |
| K132216 | BAUSCH + LOMB PEROXICLEAR 3% HYDROGEN PEROXIDE CLEANING & DI | Bausch & Lomb, Incorporated | 2013-09-09 | 54 | 0 |
| K130734 | SAUFLON MULTIPURPOSE SOLUTION | Sauflon Pharmaceuticals, Ltd. | 2013-05-15 | 58 | 0 |
| K112909 | OCD04 3% HYDROGEN PEROXIDE CLEANING AND DISINFECTING SOULTIO | Bausch & Lomb, Inc. | 2012-04-30 | 210 | 0 |
| K111877 | EZS05 CLEANING AND DISINFECTING SOLUTION, BAUSCH + LOMB EZS0 | Bausch & Lomb, Inc. | 2012-01-24 | 207 | 0 |
| K110221 | EYE-CEPT STERILE SALINE SOLUTION | Optics Laboratory, Inc. | 2011-11-01 | 280 | 0 |
| K102860 | ALCON MULTI-PIRPOSE DISINFECTING SOLUTION | Alcon Research, Ltd. | 2011-05-10 | 222 | 0 |
| K102165 | STERILE SALINE SOLUTION | Cachet Pharmaceuticals Pvt. , Ltd. | 2011-01-19 | 170 | 0 |
| K093254 | AMO BRAND MULTI-PURPOSE DISINFECTING SOLUTION | Abbott Medical Optics, Inc. | 2010-09-15 | 334 | 0 |
| K093367 | STERILE SALINE SOLUTION | Cachet Pharmaceuticals Pvt. , Ltd. | 2010-09-10 | 316 | 0 |
| K083812 | REFRESH OPTIVE LENS COMFORT REWETTING DROPS | Allergan, Inc. | 2009-07-09 | 199 | 0 |
| K071236 | ALCON MULTI-PURPOSE SOLUTION | Alcon, Inc. | 2007-12-12 | 223 | 0 |
| K070767 | EYE SEE MULTIPURPOSE CONTACT LENS SOLUTION | Lapis Lazuli International NV | 2007-07-24 | 126 | 0 |
| K071203 | SEREINE EXTRA STRENGTH DAILY CLEANER FOR SILICONE HYDROGEL ( | Optikem International, Inc. | 2007-06-13 | 43 | 0 |
| K062332 | ALTAIRE MPS#1 MULTIPURPOSE CONTACT LENS SOLUTION | Altaire Pharmaceuticals, Inc. | 2007-04-25 | 258 | 0 |
| K060924 | JSZ MULTIACTION GP CONTACT LENS SOLUTION | Szabocsik and Associates | 2006-06-28 | 85 | 0 |
| K051104 | EYE SEE MULTIPURPOSE, NO-RUB CONTACT LENS SOLUTION | Lapis Lazuli, NV | 2006-05-31 | 394 | 0 |
| K050729 | ALCON MULTI-PURPOSE DISINFECTING SOLUTION | Alcon Research, Ltd. | 2005-09-14 | 177 | 1 |
| K050250 | AQUIFY MULTIPURPOSE SOLUTION | Ciba Vision Corporation | 2005-08-10 | 188 | 0 |
| K042562 | LENS PLUS REWETTING DROPS | Advanced Medical Optics, Inc. | 2005-07-29 | 311 | 0 |
| K041008 | EYE-CEPT REWETTING DROPS | Optics Laboratory, Inc. | 2005-07-01 | 438 | 0 |
| K050517 | JSZ-MULTIPURPOSE SOLUTION | Szabocsik and Associates | 2005-04-13 | 43 | 0 |
| K042176 | AQUIFY LENS COMFORT DROPS | Ciba Vision Corporation | 2004-11-03 | 84 | 0 |
| K031753 | KARATS MULTIPURPOSE SOLUTION | Ciba Vision Corporation | 2004-10-28 | 511 | 0 |
| K033608 | AQUIFY MULTI-PURPOSE SOLUTION | Ciba Vision Corporation | 2004-02-02 | 77 | 0 |
| K031646 | BAUSCH & LOMB MULTI-PURPOSE SOLUTION NRC03 | Bausch & Lomb, Inc. | 2003-11-14 | 170 | 0 |
| K032481 | THERATEARS CONTACT LENS COMFORT DROPS | Advanced Vision Research, Inc. | 2003-11-04 | 84 | 0 |
| K030910 | CLUED UP MULTIPURPOSE SOLUTION- NO RUB | Clued UP Limited | 2003-10-10 | 200 | 0 |
| K032030 | BLINK CL LUBRICANT EYE DROPS | Advanced Medical Optics, Inc. | 2003-09-25 | 86 | 0 |
| K030522 | AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION | Ciba Vision Corporation | 2003-09-12 | 205 | 0 |
| K031957 | MODIFICATION TO KARATS MULTI-PURPOSE SOLUTION | Ciba Vision Corporation | 2003-08-14 | 50 | 0 |
| K030278 | SAUFLON MULTIPURPOSE SOLUTION - NO RUB | Sauflon Pharmaceuticals, Ltd. | 2003-07-30 | 184 | 0 |
| K031193 | SOFT (HYDROPHILIC) CONTACT LENS CARE SOLUTION | Alcon, Inc. | 2003-07-03 | 78 | 0 |
| K031522 | SOLO-CARE PLUS MULTIPURPOSE SOLUTION | Ciba Vision Corporation | 2003-06-27 | 43 | 1 |
| K031521 | AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION | Ciba Vision Corporation | 2003-06-27 | 43 | 0 |
| K030092 | COMPLETE BRAND MULTI-PURPOSE SOLUTION | Advanced Medical Optics, Inc. | 2003-04-04 | 84 | 0 |
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