510(k) · Cleared

Cleared

Eusol-C

K032422510(k) TraditionalCleared Dec 15, 2003132-day reviewClass U

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

Al.Chi.Mi.A · LYX Media, Corneal Storage

Cleared on Dec 15, 2003 as substantially equivalent to K924165 (Chiron Intraoptics, 1992) after a 132-day review. Its family tree reaches back 1 generation to 1992. 1 later device descends from it.

Decided: Dec 15, 2003
Review: 132 days
Class: Class U
Product code: LYX
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K924165 (1992). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK924165 Optisol-GS Corneal Storage MediaChiron Intraoptics · 1992
This deviceK032422 Eusol-CAl.Chi.Mi.A · 2003
Descendant · cites it directly · 0 of its ownK063617 Eusol-CAl.Chi.Mi.A · 2007

Most influential descendants

Showing 1 of 1 · See all

K063617Eusol-CAl.Chi.Mi.A · 2007 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K924165	Optisol-GS Corneal Storage Media	Chiron Intraoptics	1992	—
0 (this device)	K032422	Eusol-C	Al.Chi.Mi.A	2003	—
+1	K063617	Eusol-C	Al.Chi.Mi.A	2007	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0

FIG. 1 — Lineage of K032422, 1992–2007Source: 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 LYX? 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 LYX device

#1 K251320 XTRA4score 10.0 · 1 generation · 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
*	K924165	Optisol-GS Corneal Storage Media Summary page 1 …erile medium for hypothermic comeal storage Classification name: Not classified (3) Equivalent legally-marketed devices. Optisol-GS Comeal Storage Media, K924165 (4) Description Alchimia 510(k) Page A3 Corrected Eusol-C is sterile medium for hy…	Chiron Intraoptics	1992	—

Also cleared against K924165: 4 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
K063617	Eusol-C	Al.Chi.Mi.A	2007	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?

Its one ancestor has no recall.
Of its descendants, K063617 (Al.Chi.Mi.A, 2007) has gone furthest, with 0 descendants of its own.
4 other devices also cite its predicate K924165.

How does its category compare?

All LYX devices

LYX Media, Corneal Storage: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LYX

1in 2025

2007high 2 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LYX

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

Recalls per year · LYX

No recall names LYX since 2007.

Adverse event reports per year · LYX

1in 2021

2007high 5 (2013) · low 0 (2008)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	2	—	1
2008	0	—	0
2009	0	—	1
2010	0	—	0
2011	0	—	0
2012	0	—	4
2013	0	—	5
2014	0	—	1
2015	1	—	0
2016	1	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	1	—	1
2022	1	—	0
2023	0	—	0
2024	0	—	0
2025	1	—	0
2026	0	—	—

What is it indicated for?

Eusol-C is indicated for the storage of donor corneas for up to 14 days.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K032422 · printed Nov 6, 2026

Cite this page

510(k) Report. “K032422: Eusol-C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032422

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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