510(k) · Cleared

Cleared

Aosept Clear Care Cleaning and Disinfecting Solution

K023455510(k) TraditionalCleared Feb 28, 2003136-day reviewClass II21 CFR 886.5918

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

Ciba Vision Corporation · MRC Products, Contact Lens Care, Rigid Gas Permeable

Cleared on Feb 28, 2003 after a 136-day review. The FDA summary names its predicate without a number. 8 later devices descend from it.

Decided: Feb 28, 2003
Review: 136 days
Class: Class II
Product code: MRC
Recalls: None
Predicates: 0

8 later devices descend from it, 5 citing it directly.

This deviceK023455 Aosept Clear Care Cleaning and Disinfecting SolutionCiba Vision Corporation · 2003
Descendant · cites it directly · 3 of its ownK142284 Clear Care Plus Cleaning & Disinfectiong Solution with HydraglydeAlcon Laboratories, Inc. · 2015 · Recalled
Descendant · cites it directly · 2 of its ownK162597 Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with…Alcon Laboratories, Inc. · 2016
Descendant · 2 generations on · 1 of its ownK191872 Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting SolutionMenicon Co, Ltd. · 2020
Descendant · cites it directly · 1 of its ownK173538 Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with…Alcon Laboratories, Inc. · 2017
Descendant · cites it directly · 1 of its ownK112909 OCD04 3% Hydrogen Peroxide Cleaning and Disinfecting SoultionBausch & Lomb, Inc. · 2012

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2012high 1 (2012) · low 0 (2014)2026

Most influential descendants

Showing 5 of 8 · See all

K142284Clear Care Plus Cleaning & Disinfectiong Solution with HydraglydeAlcon Laboratories, Inc. · 2015 · cites it directly3descendants
K162597Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODiscAlcon Laboratories, Inc. · 2016 · cites it directly2descendants
K191872Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting SolutionMenicon Co, Ltd. · 2020 · 2 generations on1descendant
K173538Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODiscAlcon Laboratories, Inc. · 2017 · cites it directly1descendant
K112909OCD04 3% Hydrogen Peroxide Cleaning and Disinfecting SoultionBausch & Lomb, Inc. · 2012 · cites it directly1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K023455	Aosept Clear Care Cleaning and Disinfecting Solution	Ciba Vision Corporation	2003	—
+1	K142284	Clear Care Plus Cleaning & Disinfectiong Solution with Hydraglyde	Alcon Laboratories, Inc.	2015	1
+1	K162597	Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc	Alcon Laboratories, Inc.	2016	—
+2	K191872	Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution	Menicon Co, Ltd.	2020	—
+1	K173538	Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc	Alcon Laboratories, Inc.	2017	—
+1	K112909	OCD04 3% Hydrogen Peroxide Cleaning and Disinfecting Soultion	Bausch & Lomb, Inc.	2012	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	1	0
2013	1	0
2015	1	0
2016	1	0
2017	1	0
2019	1	0
2020	1	0
2026	1	0

FIG. 1 — Lineage of K023455, 2003–2026Source: 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 MRC? 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 MRC device

#1 K251876 cleadew GP hydra onescore 10.7 · 3 generations · no Class I recall
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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
*	—	SOLO-Care Brand Hard Solution Named without a submission number			—
†	K013512	Aosept Clear Care Cleaning and Disinfecting Solution	Ciba Vision Corporation	2001	—
†	K003345	Aosept Plus Cleaning and Disinfecting Solution	Ciba Vision Corporation	2001	—

What descends from it? (8)

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K142284	Clear Care Plus Cleaning & Disinfectiong Solution with Hydraglyde	Alcon Laboratories, Inc.	2015	3
K162597	Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc	Alcon Laboratories, Inc.	2016	2
K173538	Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc	Alcon Laboratories, Inc.	2017	1
K112909	OCD04 3% Hydrogen Peroxide Cleaning and Disinfecting Soultion	Bausch & Lomb, Inc.	2012	1
K191795	AOCup Lens Case with AODisc	Alcon Laboratories, Inc.	2019	0

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?

Of its descendants, K142284 (Alcon Laboratories, Inc., 2015) has gone furthest, with 3 descendants of its own.

How does its category compare?

All MRC devices

MRC Products, Contact Lens Care, Rigid Gas Permeable: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MRC

1in 2025

2007high 3 (2018) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MRC

51in 2018

2007high 51 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MRC

1in 2021

2007high 1 (2009) · low 0 (2007)2026

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

Adverse event reports per year · MRC

72in 2025

2007high 72 (2025) · low 0 (2008)2025

MAUDE reports naming product code MRC, 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	0	—	0	1
2008	0	—	0	0
2009	0	—	1	0
2010	1	—	0	2
2011	0	—	0	0
2012	0	—	0	3
2013	2	—	0	0
2014	0	—	0	1
2015	0	—	0	1
2016	0	—	0	2
2017	2	—	0	0
2018	3	51	0	2
2019	1	—	0	1
2020	2	—	0	3
2021	0	—	1	1
2022	0	—	0	4
2023	0	—	0	2
2024	0	—	0	2
2025	1	—	0	72
2026	0	—	0	—

What is it indicated for?

AOSept Clear Care Cleaning and Disinfecting Solution is indicated for use in cleaning, daily protein removal, disinfecting, and storing of soft (hydrophilic) or rigid gas permeable (fluoro silicone acrylate and silicone acrylate) contact lenses as recommended by your eye care practitioner.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K023455 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023455: Aosept Clear Care Cleaning and Disinfecting Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023455

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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