510(k) · Cleared

Cleared

OCD04 3% Hydrogen Peroxide Cleaning and Disinfecting Soultion

K112909510(k) TraditionalCleared Apr 30, 2012210-day reviewClass II21 CFR 886.5928

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

Bausch & Lomb, Inc. · LPN Accessories, Soft Lens Products

Cleared on Apr 30, 2012 as substantially equivalent to K022687 (Ciba Vision Corporation, 2002) and 1 other predicate after a 210-day review. Its family tree reaches back 1 generation to 2002. 1 later device descends from it.

Decided: Apr 30, 2012
Review: 210 days
Class: Class II
Product code: LPN
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K022687 (2002). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK022687 Aosept Clear Care Cleaning and Disinfecting SolutionCiba Vision Corporation · 2002
This deviceK112909 OCD04 3% Hydrogen Peroxide Cleaning and Disinfecting SoultionBausch & Lomb, Inc. · 2012
Descendant · cites it directly · 0 of its ownK132216 Bausch + Lomb Peroxiclear 3% Hydrogen Peroxide Cleaning &…Bausch & Lomb, Incorporated · 2013 · Recalled

Most influential descendants

Showing 1 of 1 · See all

K132216Bausch + Lomb Peroxiclear 3% Hydrogen Peroxide Cleaning & Disinfecting SolutionBausch & Lomb, Incorporated · 2013 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K022687	Aosept Clear Care Cleaning and Disinfecting Solution	Ciba Vision Corporation	2002	—
0 (this device)	K112909	OCD04 3% Hydrogen Peroxide Cleaning and Disinfecting Soultion	Bausch & Lomb, Inc.	2012	—
+1	K132216	Bausch + Lomb Peroxiclear 3% Hydrogen Peroxide Cleaning & Disinfecting Solution	Bausch & Lomb, Incorporated	2013	1

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	1	0

FIG. 1 — Lineage of K112909, 2002–2013Source: 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 LPN? 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 LPN device

#1 K253795 MeniSept 3% Hydrogen Peroxide Cleaning &…score 12.7 · 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? (2)

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
*	K022687	Aosept Clear Care Cleaning and Disinfecting Solution Summary page 1 …8) Product Code LPN, MRC 3.0 Predicate Device: The predicate device is Cilba, Clear Care Cleaning and Disinfecting Solution cleared in K022687 on November 19, 2002 and K023455 on February 28, 2003. 4.0 Device Description: Bausch + Lomb OCDC4 3% Hydrogen Peroxide…	Ciba Vision Corporation	2002	—
*	K023455	Aosept Clear Care Cleaning and Disinfecting Solution Summary page 1 …LPN, MRC 3.0 Predicate Device: The predicate device is Cilba, Clear Care Cleaning and Disinfecting Solution cleared in K022687 on November 19, 2002 and K023455 on February 28, 2003. 4.0 Device Description: Bausch + Lomb OCDC4 3% Hydrogen Peroxide Cleaning and Disinfecting S…	Ciba Vision Corporation	2003	—

Also cleared against K022687: 5 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K132216	Bausch + Lomb Peroxiclear 3% Hydrogen Peroxide Cleaning & Disinfecting Solution	Bausch & Lomb, Incorporated	2013	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?

None of the 2 ancestors has a recall.
Of its descendants, K132216 (Bausch & Lomb, Incorporated, 2013) has gone furthest, with 0 descendants of its own.
5 other devices also cite its predicate K022687.

How does its category compare?

All LPN devices

LPN Accessories, Soft Lens Products: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · LPN

2in 2022

2007high 4 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LPN

167in 2020

2007high 222 (2011) · low 59 (2016)2026

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

Recalls per year · LPN

1in 2020

2007high 2 (2007) · low 0 (2008)2026

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

Adverse event reports per year · LPN

40in 2025

2007high 2,666 (2017) · low 40 (2025)2025

MAUDE reports naming product code LPN, 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	4	175	2	1,151
2008	0	—	0	153
2009	1	—	2	121
2010	2	—	2	241
2011	3	222	1	273
2012	2	—	0	268
2013	2	—	0	84
2014	0	—	0	105
2015	2	—	0	176
2016	3	59	1	498
2017	1	—	0	2,666
2018	0	—	0	95
2019	2	—	0	60
2020	3	167	1	82
2021	2	—	0	51
2022	2	—	0	62
2023	0	—	0	84
2024	0	—	0	76
2025	0	—	0	40
2026	1	—	0	—

What is it indicated for?

Bausch + Lomb OCDO4 3% Hydrogen Peroxide Cleaning and Disinfecting Solution is indicated for the daily cleaning, removal of protein deposits, disinfection, and storage of soft (hydrophilic) contact lenses (including silicone hydrogel) and rigid gas permeable contact lenses, as recommended by your eye care practitioner.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K112909 · printed Nov 5, 2026

Cite this page

510(k) Report. “K112909: OCD04 3% Hydrogen Peroxide Cleaning and Disinfecting Soultion.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K112909

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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