Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
OCT — Predicate Candidate Screening
27 FDA 510(k) clearances under this product code; the 50 most recent screened below.
128 daysmedian FDA review time
345 days90th percentile
27clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251068 | KnoxFog Anti-fogging Device | Uv One Hygienics, Inc. | 2025-08-27 | 142 | 0 |
| K231822 | GOLFF Sterile Anti-Fog Solution | Batrik Medical Manufacturing, Inc. | 2024-02-26 | 250 | 0 |
| K221293 | E-Brik Visualization Assistant | Jdi Surgical, Inc. | 2022-07-07 | 64 | 0 |
| K190864 | Konix Anti-Fog Solution | Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler | 2020-08-27 | 512 | 0 |
| K181887 | AMD Anti-Fog Solution | Advanced Medical Design Co., Ltd. | 2019-01-22 | 193 | 0 |
| K163257 | VitreOx Anti-fog Solution | Sio2 Nanotech, LLC | 2017-05-24 | 191 | 0 |
| K152948 | Medline Anti-Fog Solution | Medline Industries, Inc. | 2016-02-04 | 121 | 0 |
| K120821 | LLICS(TM) LAPARASCOPIC LENS INTERNAL CLEANING SYSTEM | Misder, LLC | 2012-05-11 | 53 | 0 |
| K111622 | UNIMAX ANTI-FOG SOLUTION | Unimax Medical Systems, Inc. | 2011-09-09 | 91 | 0 |
| K102452 | DEFOGGING AND CLEANING SOLUTION- FLO-X | Minimally Invasive Devices, LLC | 2010-12-23 | 118 | 0 |
| K080613 | CLEAR-VU SYSTEM, MODELS: CVL-01-1000, CVL-01-1030, CVL-01-10 | Minimally Invasive Devices, LLC | 2008-11-06 | 247 | 0 |
| K063587 | XODUS MEDICAL ANTI-FOG SOLUTION | Xodus Medical, Inc. | 2007-01-09 | 39 | 0 |
| K051979 | ORS MODEL 6000 ENDOSCOPE HOLDER | O.R. Solutions, Inc. | 2005-08-30 | 40 | 0 |
| K022826 | CLEAR-IT ANTI-FOG, MODEL PS003 | Preservation Solutions, Inc. | 2002-10-09 | 44 | 0 |
| K993604 | ENDOSCOPIC ANTI FOG DEVICE | Mectra Labs, Inc. | 2000-03-03 | 130 | 0 |
| K982465 | DEROYAL INDUSTRIES, INC. DEFOGGER | Deroyal Industries, Inc. | 1998-08-11 | 27 | 1 |
| K974454 | CLEARFIELD ANTI-FOG STERILE WIPE, PRODUCT NUMBER 300-004 | Tucson Medical Corp. | 1997-12-18 | 23 | 0 |
| K945732 | FOG FREE | Tonn Chemical Co., Inc. | 1995-01-04 | 42 | 0 |
| K942576 | CLEAR LENS ENDOSCOPIC FOG REDUCTION DEVICE | White Knight Healthcare | 1994-07-05 | 35 | 0 |
| K923843 | FOGLESS | Sorex Medical | 1994-03-25 | 602 | 0 |
| K933618 | EAGLE MEDICAL ANTI-FOG KIT | Eagle Medical Intl. | 1994-03-07 | 231 | 0 |
| K934291 | SURGICOT FOG FREE | Ssa Aquisition Corp. | 1994-02-28 | 179 | 0 |
| K932300 | FOG CONTROL, LENS FOG REDUCTION DEVICE | Highpoint Medical Corp. | 1993-09-17 | 128 | 0 |
| K925659 | U.C.E.Z. LENS CLEANER KIT | Anago, Inc. | 1993-09-17 | 345 | 0 |
| K932449 | DR. FOG | O.R. Concepts, Inc. | 1993-08-11 | 83 | 2 |
| K904871 | MEDI-KLEER | North American Marketing Corp. | 1991-09-17 | 323 | 0 |
| K905590 | UCEZ - STERILE LENS FOG REDUCTION DEVICE | Inman Liebelt Corp. | 1991-05-10 | 148 | 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