Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Abbott Medical Optics, Inc. · Predicate Candidate Screening
13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
129 daysmedian FDA review time
232 days90th percentile
13clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K170322 | Catalys Precision Laser System | Abbott Medical Optics, Inc. | 2017-05-19 | 107 | 0 |
| K160236 | Dual Pump Pack | Abbott Medical Optics, Inc. | 2016-04-27 | 86 | 1 |
| K151636 | AMO WHITESTAR Signature Pro Phacoemulsification System, WHIT | Abbott Medical Optics, Inc. | 2015-10-19 | 124 | 0 |
| K151783 | COMPACT INTUITIV Multiple-Use Pack | Abbott Medical Optics, Inc. | 2015-09-02 | 63 | 0 |
| K143434 | One Series ULTRA Cartridge, The UNFOLDER Platinum 1 Series | Abbott Medical Optics, Inc. | 2015-05-06 | 156 | 0 |
| K133115 | COMPACT INTUITIV; SYSTEM, WIRELESS REMOTE CONTROL, FOUR-BUTT | Abbott Medical Optics, Inc. | 2014-02-27 | 150 | 1 |
| K121721 | LAMINAR FLOW PHACO TIPS AND IRRIGATION SLEEVE (21G, REUSABLE | Abbott Medical Optics, Inc. | 2012-10-15 | 125 | 1 |
| K113151 | IFS LASER SYSTEM | Abbott Medical Optics, Inc. | 2012-03-08 | 135 | 0 |
| K111446 | SOVEREIGN COMPACT PHACOEMULSIFICATION SYSTEM | Abbott Medical Optics, Inc. | 2011-12-21 | 211 | 1 |
| K111882 | LAMINAR FLOW PHACO TIPS | Abbott Medical Optics, Inc. | 2011-11-07 | 129 | 0 |
| K111697 | AMO WHITESTAR SIGNATURE PHACOEMULSIFICATION SYSTEM | Abbott Medical Optics, Inc. | 2011-09-27 | 102 | 0 |
| K103023 | UNIT, PHACOFRAGMENTATION | Abbott Medical Optics, Inc. | 2011-06-01 | 232 | 0 |
| K093254 | AMO BRAND MULTI-PURPOSE DISINFECTING SOLUTION | Abbott Medical Optics, Inc. | 2010-09-15 | 334 | 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