Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LYL · Predicate Candidate Screening
22 FDA 510(k) clearances under this product code; the 50 most recent screened below.
165 daysmedian FDA review time
255 days90th percentile
22clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K211361 | 3N Contact Lenses Adjunct Cleaner | Suzhou 3N Biological Technology Co., Ltd. | 2022-01-13 | 255 | 0 |
| K210300 | VueSonic One Contact Lens Cleaning System, VueSonic Advance | Vuesonic, LLC | 2021-04-01 | 57 | 0 |
| K083757 | BPZ02 MULTIPURPOSE SOLUTION | Bausch & Lomb, Inc. | 2009-11-18 | 336 | 2 |
| K021699 | AUTOLENS CLEANING AND DISINFECTING UNIT | Autolens, Inc. | 2002-12-16 | 208 | 0 |
| K022687 | AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION | Ciba Vision Corporation | 2002-11-19 | 98 | 0 |
| K020802 | RENUT MULTIPLUS MULLTI-PURPOSE SOLUTION | Bausch & Lomb, Incorporated | 2002-05-31 | 80 | 2 |
| K994021 | CONTACLAIR MULTI-PURPOSE CONTACT LENS SOLUTION | Strieter Clinical Research Laboratories, Inc. | 2000-02-22 | 88 | 0 |
| K991965 | PURILENS SYSTEM FOR CLEANING AND DISINFECTING CONTACT LENSES | Purilens, Inc. | 1999-10-01 | 113 | 0 |
| K982115 | LENSERVER AUTOMATIC CONTACT LENS CLEANING ACCESSORY | Rim-Wide Companies, Inc. | 1999-01-13 | 211 | 0 |
| K974724 | SOFTMATE AUTOMATIC LENS CLEANING UNIT, CLENSATRON 700 CL AUT | Lens Comfort, Inc. | 1998-03-02 | 74 | 0 |
| K964222 | ACU-CLENS CLEANING SYSTEM FOR CONTACT LENS CLEANING | Paladin Medical, Inc. | 1996-12-20 | 59 | 0 |
| K962112 | NEW COMFORT CONTACT LENS CARE ACCESSORY | Lens Comfort, Inc. | 1996-11-29 | 182 | 0 |
| K950940 | OPTI PADS | Karlen Mfg., Inc. | 1995-06-26 | 119 | 0 |
| K923816 | CONTACT LENS CLEANING ACCESSORY | Cramer Ent., Inc. | 1993-03-08 | 221 | 0 |
| K921615 | LENSONIC(TM) CONTACT LENS CARE ACCESSORY | Personal Professional Products, Inc. | 1992-11-05 | 213 | 0 |
| K921882 | THE CLEANER ACCESSORY | Eaton Medical Corp. | 1992-08-25 | 126 | 0 |
| K902920 | TURBOTRON 20/20 | Prestige Manufacturing Snd Bhd | 1991-10-10 | 464 | 0 |
| K904824 | EASY EYES TM CONTACT LENS CLEANING MACHINE | Eaton Medical Corp. | 1991-07-05 | 253 | 0 |
| K902306 | THE VISONIC DOME(TM) | Vista Vision | 1990-12-21 | 213 | 0 |
| K892372 | SPIN-CLEAN CLEANING UNIT | Willmar Contact Lens Co. | 1989-06-23 | 78 | 0 |
| K884414 | CLENSATRON AUTOMATIC CONTACT LENS CLEANER | Questech Intl., Inc. | 1988-12-29 | 70 | 0 |
| K881739 | LENZ CLENZER | Lens Care, Inc. | 1988-10-07 | 165 | 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