Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MSS — Predicate Candidate Screening
63 FDA 510(k) clearances under this product code; the 50 most recent screened below.
105 daysmedian FDA review time
274 days90th percentile
63clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261174 | RxSight® Insertion Device | Rxsight, Inc. | 2026-06-10 | 62 | 0 |
| K252540 | ACCUJECT Injector Set 2.1-1P (LP604590) | Medicel AG | 2025-09-16 | 35 | 0 |
| K242389 | EyeGility™ Inserter for Preloaded enVista IOLs | Bausch & Lomb, Incorporated | 2024-10-10 | 59 | 0 |
| K231106 | Accuject Refra Injector AR2900 | Medicel AG | 2023-09-19 | 153 | 0 |
| K231838 | RxSight® Insertion Device (63002) | Rxsight, Inc. | 2023-08-15 | 54 | 0 |
| K231466 | RxSight Insertion Device | Rxsight, Inc. | 2023-06-12 | 24 | 0 |
| K212039 | CLAREON MONARCH IV IOL Delivery System | Alcon Laboratories, Inc. | 2021-08-23 | 54 | 0 |
| K200057 | bioli lOL Delivery System | Ast Products, Inc. | 2020-06-04 | 143 | 0 |
| K192926 | RxSight Insertion Device | Rxsight, Inc. | 2020-01-17 | 93 | 0 |
| K192005 | Bausch + Lomb PreVue Inserter for enVista Preloaded | Bausch & Lomb, Inc. | 2019-10-04 | 67 | 0 |
| K191949 | UNFOLDER Vitan Inserter | Johnson & Johnson Surgical Vision, Inc. | 2019-09-13 | 53 | 0 |
| K182965 | BL-Cart IOL Delivery Cartridge | Ast Products, Inc. | 2019-03-29 | 155 | 0 |
| K181401 | RxSight Insertion Device | Rxsight, Inc. | 2018-07-26 | 58 | 0 |
| K172228 | pioli IOL Delivery System | Ast Products, Inc. | 2017-12-15 | 143 | 0 |
| K173480 | Crystalsert Lens Delivery System | Bausch & Lomb, Inc. | 2017-12-11 | 28 | 0 |
| K172375 | MicroSTAAR Injector System Cartridges | STAAR Surgical Company | 2017-09-06 | 30 | 0 |
| K161776 | Lenstec LC Injection system | Lenstec, Inc. | 2016-11-29 | 153 | 0 |
| K161012 | Easy-Load Lens Delivery System | Bausch and Lomb, Inc., | 2016-07-06 | 86 | 0 |
| K151102 | Bausch + Lomb Injector System | Bausch & Lomb, Inc. | 2015-05-22 | 28 | 0 |
| K143434 | One Series ULTRA Cartridge, The UNFOLDER Platinum 1 Series | Abbott Medical Optics, Inc. | 2015-05-06 | 156 | 0 |
| K142056 | LIOLI IOL DELIVERY SYSTEM | Ast Products, Inc. | 2015-04-09 | 254 | 0 |
| K143307 | RaySert PLUS Injector, Single Use Soft Tipped Disposable Inj | Rayner Intraocular Lenses , Ltd. | 2014-12-18 | 30 | 0 |
| K141091 | RAYSERT PLUS INJECTOR | Rayner Intraocular Lenses , Ltd. | 2014-05-28 | 30 | 0 |
| K132002 | SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR, RAYSERT SINGLE U | Rayner Intraocular Lenses , Ltd. | 2014-03-27 | 269 | 0 |
| K131958 | BAUSCH & LOMB INJECTOR SYSTEM | Bausch & Lomb | 2014-01-09 | 196 | 0 |
| K133146 | BAUSCH + LUMB, VIS100 INJECTOR SYSTEM | Bausch & Lomb | 2014-01-03 | 78 | 0 |
| K132481 | EASY-LOAD LENS DELIVERY SYSTEM | Bausch & Lomb | 2013-12-27 | 141 | 0 |
| K122848 | LENSTEC LC INJECTION SYSTEM | Lenstec, Inc. | 2013-10-18 | 395 | 0 |
| K132593 | CRYSTALSERT DELIVERY SYSTEM | Bausch & Lomb | 2013-09-17 | 29 | 0 |
| K123736 | CRYSTALSERT DELIVERY SYSTEM | Bausch & Lomb | 2013-05-16 | 162 | 0 |
| K123888 | Z CARTRIDGE IOL DELIVERY SYSTEM | Aaren Scientific, Inc. | 2013-04-15 | 118 | 0 |
| K113852 | BAUSCH & LOMB IOL INJECTOR | Bausch & Lomb, Inc. | 2012-09-28 | 274 | 0 |
| K112977 | MONARCH III IOL DELIVERY SYSTEM, MONARCH III C CARTRIDGE, MO | Alcon Research, Ltd. | 2012-03-27 | 173 | 1 |
| K101774 | MONARCH III IOL DELIVERY SYSTEM; MONARCH III P CATRIDGE; MON | Alcon Manufacturing, Ltd. | 2011-10-13 | 476 | 0 |
| K103495 | ASICO SOFTIP INJECTOR SYSTEM | Asico, LLC | 2011-06-29 | 212 | 0 |
| K101782 | MICROSTAAR MSI INJECTOR SYSTEM CARTRIDGE | Staar Japan | 2010-12-22 | 180 | 0 |
| K101134 | VISIAN NANOPOINT 2.0 INJECTOR MODEL LP604430 | Medicel AG | 2010-08-09 | 109 | 0 |
| K091507 | RAYNER SMALL INCISION SINGLE USE SOFT TIPPED INJECTOR, MODEL | Rayner Intraocular Lenses , Ltd. | 2009-12-04 | 197 | 0 |
| K092023 | NAVIJECT SUB2-1P, MODEL: LP604430 | Medicel AG | 2009-07-28 | 22 | 0 |
| K082871 | XACT LENS INSERTER SYSTEM, MODELS 6MM, 7MM | Sis Ltd., Surgical Instrument Systems | 2009-07-09 | 283 | 0 |
| K090161 | EPIPHANY INJECTION SYSTEM | Staar Surgical Co. | 2009-06-09 | 138 | 0 |
| K081346 | HOYA IS INJECTOR SYSTEM | Hoya Surgical Optics, Inc. | 2009-03-23 | 313 | 0 |
| K082944 | CRYSTALSERT CRYSTALENS DELIVERY SYSTEM | Bausch & Lomb, Inc. | 2008-10-16 | 14 | 0 |
| K081545 | ONE SERIES ULTRA CARTRIDGE, MODEL 1VIPR30 | Advanced Medical Optics, Inc. | 2008-10-02 | 122 | 0 |
| K081455 | RAYNER SINGLE USE SMALL INCISION DISPOSABLE INJECTOR, MODEL | Rayner Surgical, Inc. | 2008-09-05 | 105 | 0 |
| K073591 | MICROSTAAR MSI INJECTOR FOAM TIP SYSTEM | Staar Surgical Co. | 2008-03-13 | 84 | 0 |
| K073586 | MICROSTAAR INDIGO INJECTOR FOAM TIP SYSTEM | Staar Surgical Co. | 2008-03-13 | 84 | 0 |
| K073010 | ROYALE AE 9036 LSP INJECTOR | Asico, LLC | 2007-11-07 | 13 | 0 |
| K063802 | LENSTEC LC INJECTION SYSTEM | Lenstec, Inc. | 2007-05-07 | 136 | 0 |
| K062612 | RAYNER SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR, MODEL R-I | Rayner Surgical, Inc. | 2006-12-13 | 99 | 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