Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MXK — Predicate Candidate Screening
23 FDA 510(k) clearances under this product code; the 50 most recent screened below.
193 daysmedian FDA review time
303 days90th percentile
23clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251848 | Pentacam® Cornea OCT | Oculus Optikgeräte GmbH | 2026-03-13 | 270 | 0 |
| K252348 | Tomey Optical Biometer OA-2000 (OA-2000) | Tomey Corporation | 2025-12-18 | 142 | 0 |
| K223700 | BOSS™ | Intelon Optics, Inc. | 2024-08-16 | 613 | 0 |
| K222933 | MYAH | Visia Imaging S.R.L. | 2023-06-29 | 276 | 0 |
| K211868 | MYAH | Visia Imaging S.R.L. | 2022-03-01 | 258 | 0 |
| K202989 | Myopia Master | Oculus Optikgeräte GmbH | 2021-07-14 | 287 | 1 |
| K201724 | Pentacam AXL Wave | Oculus Optikgerate GmbH | 2020-10-21 | 120 | 1 |
| K182659 | Galilei G6 Lens Professional | Sis Ag, Surgical Instrument Systems | 2019-07-25 | 303 | 0 |
| K191051 | ARGOS | Santec Corporation | 2019-05-16 | 27 | 0 |
| K152311 | Pentacam AXL | Oculus Optikgerate GmbH | 2016-01-20 | 159 | 1 |
| K150754 | ARGOS | Santec Corporation | 2015-10-02 | 193 | 0 |
| K073508 | PARKONE | Oculus Optikgerate GmbH | 2008-09-11 | 273 | 0 |
| K071183 | ALLEGRO OCULYZER | Wavelight AG | 2007-07-20 | 81 | 0 |
| K052935 | HEIDELBERG ENGINEERING SLITLAMP-OCT (SL-OCT) | Heidelberg Engineering | 2006-01-13 | 86 | 0 |
| K051940 | CM 3910 ROTATING DOUBLE SCHEIMPFLUG CAMERA | Sis Ltd., Surgical Instrument Systems | 2005-09-28 | 72 | 0 |
| K041841 | PACHYCAM | Oculus Optikgerate GmbH | 2005-01-28 | 204 | 0 |
| K042742 | HEIDELBERG RETINA TOMOGRAPH II / ROSTOCK CORNEA MODULE (HRT | Heidelberg Engineering | 2004-10-13 | 9 | 0 |
| K031788 | PATHFINDER | Massie Research Laboratories, Inc. | 2004-09-02 | 450 | 0 |
| K040913 | NGDI (NEXT GENERATION DIAGNOSTIC INSTRUMENT) | Bausch & Lomb | 2004-07-23 | 106 | 0 |
| K030393 | OPTICAL LOW COHERENCE REFLECTOMETRY (OLCR) PACHYMETER | Haag-Streit Holding AG | 2003-09-25 | 232 | 0 |
| K030719 | PENTACAM SCHEIMPFLUG CAMERA | Oculus Optikgerate GmbH | 2003-09-16 | 193 | 0 |
| K991284 | ANTERIOR EYE-SEGMENT ANALYSIS SYSTEM | Nidek, Inc. | 1999-08-06 | 113 | 0 |
| K984443 | ORBSCAN | Technolas Perfect Vision GmbH | 1999-03-05 | 81 | 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