Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Allergan, Inc. · Predicate Candidate Screening
33 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
72 daysmedian FDA review time
153 days90th percentile
33clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K190674 | REFRESH RELIEVA For CONTACTS | Allergan, Inc. | 2019-08-08 | 146 | 0 |
| K161457 | XEN Glaucoma Treatment System | Allergan, Inc. | 2016-11-21 | 179 | 0 |
| K143354 | Natrelle 133 Plus Tissue Expander | Allergan, Inc. | 2015-08-20 | 269 | 1 |
| K083812 | REFRESH OPTIVE LENS COMFORT REWETTING DROPS | Allergan, Inc. | 2009-07-09 | 199 | 0 |
| K051852 | SINGLE AMPLIFIER FOR BOTOX | Allergan, Inc. | 2005-09-14 | 68 | 0 |
| K014202 | COMPLETE BRAND MULTI-PURPOSE SOLUTION | Allergan, Inc. | 2002-02-20 | 61 | 2 |
| K013479 | COMPLETE BRAND MULTI-PURPOSE SOLUTION | Allergan, Inc. | 2002-02-11 | 115 | 0 |
| K003252 | COMPLETE BRAND MULTI-PURPOSE SOLUTION | Allergan, Inc. | 2001-02-21 | 127 | 0 |
| K003638 | MOJAVE CATARACT EXTRACTION SYSTEM | Allergan, Inc. | 2001-02-13 | 81 | 0 |
| K003109 | COMPLETE BRAND LUBRICATING AND REWETTING DROPS | Allergan, Inc. | 2000-11-21 | 48 | 0 |
| K000164 | COMPLETE BRAND COMFORTPLUS MULTI-PURPOSE SOLUTION | Allergan, Inc. | 2000-06-02 | 135 | 0 |
| K992028 | REFRESH CONTACTS LUBRICATING AND REWETTING DROPS | Allergan, Inc. | 1999-10-07 | 113 | 0 |
| K984383 | ULTRACARE NEUTRALIZING TABLETS | Allergan, Inc. | 1998-12-18 | 10 | 0 |
| K983150 | COMPLETE BRAND LUBRICATING AND REWETTING DROPS | Allergan, Inc. | 1998-11-25 | 77 | 0 |
| K981168 | COMPLETE BRAND MULTI-PURPOSE SOLUTION, COMPLETE BRAND LUBRIC | Allergan, Inc. | 1998-09-01 | 153 | 1 |
| K980775 | COMPLETE BRAND MULTI-PURPOSE SOLUTION | Allergan, Inc. | 1998-07-06 | 126 | 0 |
| K981116 | SOVEREIGN CATARACT EXTRACTION SYSTEM | Allergan, Inc. | 1998-05-19 | 53 | 1 |
| K971186 | AMO DIPLOMAX/OPSYS CONSOLE | Allergan, Inc. | 1997-06-13 | 73 | 0 |
| K962402 | AMO PRESTIGE DAY PACK (ALLERGAN, INC.) | Allergan, Inc. | 1996-09-19 | 90 | 0 |
| K961242 | AMO PHACOFLEX II INTERSECTION SYSTEM | Allergan, Inc. | 1996-06-17 | 77 | 0 |
| K874543 | MODEL OPO-32 IRRIGATION SLEEVE | Allergan, Inc. | 1988-01-14 | 72 | 0 |
| K870807 | BKS-1000 REFRACTIVE SET USE IN KERATOREFRACTIVE | Allergan, Inc. | 1987-05-29 | 91 | 0 |
| K864065 | BKS-42 DISPOSABLE VACUUM TUBING PACK | Allergan, Inc. | 1986-12-15 | 56 | 0 |
| K864003 | PACO-FOLDER (TM) INTRAOCULAR LENS FORCEPS | Allergan, Inc. | 1986-10-31 | 17 | 0 |
| K863201 | NEW USE FOR ACUVAC SUCTION RESERVOIR 400CC | Allergan, Inc. | 1986-08-29 | 10 | 0 |
| K861643 | STYLEKEEPER CONTACT LENS CARRYING CASE | Allergan, Inc. | 1986-06-02 | 33 | 0 |
| K861642 | LENSKEEPER CONTACT LENS CARRYING CASE | Allergan, Inc. | 1986-05-29 | 29 | 0 |
| K822706 | PRE-SERT | Allergan, Inc. | 1982-10-22 | 45 | 0 |
| K822707 | CLEAN-N-SOAK | Allergan, Inc. | 1982-10-18 | 41 | 0 |
| K821054 | TOTAL | Allergan, Inc. | 1982-05-13 | 28 | 0 |
| K821052 | SOAKARE | Allergan, Inc. | 1982-05-13 | 28 | 0 |
| K821051 | LIQUIFILM WETTING SOLUTION | Allergan, Inc. | 1982-05-13 | 28 | 0 |
| K821055 | BLINK-N-CLEAN | Allergan, Inc. | 1982-05-10 | 25 | 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