510(k) · Cleared

Cleared

Unimax Anti-Fog Solution

K111622510(k) TraditionalCleared Sep 9, 201191-day reviewClass II21 CFR 876.1500

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Unimax Medical Systems, Inc. · OCT Anti Fog Solution And Accessories, Endoscopy

Cleared on Sep 9, 2011 as substantially equivalent to K063587 (Xodus Medical, Inc., 2007) after a 91-day review. Its family tree reaches back 2 generations to 2002.

Decided: Sep 9, 2011
Review: 91 days
Class: Class II
Product code: OCT
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K022826 (2002). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK022826 Clear-IT Anti-Fog, Model PS003Preservation Solutions, Inc. · 2002
1 generation backK063587 Xodus Medical Anti-Fog SolutionXodus Medical, Inc. · 2007
This deviceK111622 Unimax Anti-Fog SolutionUnimax Medical Systems, Inc. · 2011

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K022826	Clear-IT Anti-Fog, Model PS003	Preservation Solutions, Inc.	2002	—
−1	K063587	Xodus Medical Anti-Fog Solution	Xodus Medical, Inc.	2007	—
0 (this device)	K111622	Unimax Anti-Fog Solution	Unimax Medical Systems, Inc.	2011	—

FIG. 1 — Lineage of K111622, 2002–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in OCT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new OCT device

#1 K251068 KnoxFog Anti-fogging Devicescore 10.8 · 4 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K063587	Xodus Medical Anti-Fog Solution Summary page 4 …Endoscope And/ Or Accessories \|\| 876.1500 Gastroenterology/Urology KOG Xodus Me:dical Anti-Fog Solution Xodus Medical, Inc. 510(k) Number or Clearance Information: K063587 .. Unimax Medical Systems Inc. Unimax Anti-Fog Solution 510(k) Notification 5.5 Intended Use and Indications fo…	Xodus Medical, Inc.	2007	—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 4.7 years on median.
None of the 2 ancestors has a recall.

How does its category compare?

All OCT devices

OCT Anti Fog Solution And Accessories, Endoscopy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · OCT

1in 2025

2007high 1 (2007) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OCT

Too few OCT 510(k)s in any year since 2007 to give a median.

Recalls per year · OCT

1in 2022

2007high 1 (2022) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · OCT

13in 2025

2007high 27 (2016) · low 0 (2007)2025

MAUDE reports naming product code OCT, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	1	—	0	0
2008	1	—	0	0
2009	0	—	0	0
2010	1	—	0	0
2011	1	—	0	0
2012	1	—	0	0
2013	0	—	0	0
2014	0	—	0	0
2015	0	—	0	13
2016	1	—	0	27
2017	1	—	0	18
2018	0	—	0	20
2019	1	—	0	20
2020	1	—	0	14
2021	0	—	0	16
2022	1	—	1	10
2023	0	—	0	13
2024	1	—	0	9
2025	1	—	0	13
2026	0	—	0	—

What is it indicated for?

The Unimax Anti-Fog Solution is intended to be used to prevent “fogging” (caused by condensation) on the lenses of endoscopic/laparoscopic instruments which are likely to fog during use.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K111622 · printed Nov 6, 2026

Cite this page

510(k) Report. “K111622: Unimax Anti-Fog Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111622

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026