Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bausch & Lomb, Incorporated — Predicate Candidate Screening
27 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
92 daysmedian FDA review time
227 days90th percentile
27clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242389 | EyeGility™ Inserter for Preloaded enVista IOLs | Bausch & Lomb, Incorporated | 2024-10-10 | 59 | 0 |
| K230954 | Samfilcon B Custom Contact Lens | Bausch + Lomb, Incorporated | 2023-11-17 | 227 | 0 |
| K220613 | Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens | Bausch & Lomb, Incorporated | 2023-03-08 | 370 | 0 |
| K222541 | Bausch + Lomb Preservative Free Lubricating and Rewetting Dr | Bausch & Lomb, Incorporated | 2022-12-06 | 106 | 0 |
| K211786 | Independent Corneal Viewing Chamber (IVC-21) | Bausch + Lomb, Incorporated | 2021-12-03 | 177 | 0 |
| K202932 | ABT12 multi-purpose solution | Bausch & Lomb, Incorporated | 2021-05-28 | 241 | 0 |
| K210975 | Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens | Bausch & Lomb, Incorporated | 2021-05-24 | 53 | 0 |
| K200416 | Boston One Step Liquid Enzymatic Cleaner | Bausch & Lomb, Incorporated | 2020-09-23 | 216 | 0 |
| K200528 | Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lom | Bausch + Lomb, Incorporated | 2020-06-02 | 92 | 0 |
| K183167 | Boston ES (enflufocon A) Rigid Gas Permeable Contact Lens; B | Bausch & Lomb, Incorporated | 2019-02-12 | 89 | 0 |
| K182249 | Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens | Bausch & Lomb, Incorporated | 2018-11-30 | 102 | 0 |
| K181627 | Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + | Bausch & Lomb, Incorporated | 2018-08-10 | 51 | 0 |
| K173089 | Bausch + Lomb Boston Original Cleaner, Bausch + Lomb Boston | Bausch & Lomb, Incorporated | 2017-11-27 | 59 | 0 |
| K173365 | Bausch + Lomb Boston Scleral Lens Case | Bausch & Lomb, Incorporated | 2017-11-17 | 22 | 0 |
| K171404 | BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B) | Bausch + Lomb, Incorporated | 2017-07-17 | 66 | 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 |
| K151918 | Biotrue ONEday with NaturMoist, Biotrue ONEday for Presbyopi | Bausch & Lomb, Incorporated | 2016-02-11 | 213 | 0 |
| K143632 | Bausch + Lomb Biotrue ONEday for Astigmatism(nesofilcon A) S | Bausch & Lomb, Incorporated | 2015-02-13 | 53 | 0 |
| K132715 | BAUSCH + LOMB BIOTURE ONEDAY FOR PRESBYOPIA (NESOFILCON A) C | Bausch & Lomb, Incorporated | 2013-12-20 | 112 | 0 |
| K132216 | BAUSCH + LOMB PEROXICLEAR 3% HYDROGEN PEROXIDE CLEANING & DI | Bausch & Lomb, Incorporated | 2013-09-09 | 54 | 0 |
| K113703 | BAUSCH + LOMB NESOFILCON A CONTACT LENS | Bausch & Lomb, Incorporated | 2012-06-05 | 172 | 1 |
| K053124 | BOSTON ES (ENFLUFOCON A), BOSTON EO (ENFLUFOCON B) AND BOSTO | Bausch & Lomb, Incorporated | 2006-01-30 | 84 | 0 |
| K024289 | BOSTON BL-1000-SIM08 MULTI-ACTION SOLUTION | Bausch & Lomb, Incorporated | 2003-05-02 | 130 | 0 |
| K022128 | BOSTON EQUALENS II (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT | Bausch & Lomb, Incorporated | 2002-08-22 | 52 | 0 |
| K020802 | RENUT MULTIPLUS MULLTI-PURPOSE SOLUTION | Bausch & Lomb, Incorporated | 2002-05-31 | 80 | 2 |
| K013762 | RIGID GAS PERMEABLE CONTACT LENS | Bausch & Lomb, Incorporated | 2002-04-03 | 141 | 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