510(k) Report

510(k) · Cleared

Cleared

Optisol-GS Corneal Storage Media

K924165510(k) TraditionalCleared Oct 6, 199248-day reviewClass U

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

Chiron Intraoptics · LYX Media, Corneal Storage

Cleared on Oct 6, 1992 after a 48-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.

Decided
Oct 6, 1992
Review
48 days
Class
Class U
Product code
LYX
Recalls
None
Predicates
0

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

Descendants, by year cleared 2003: 1 descendant cleared2007: 2 descendants cleared2022: 1 descendant cleared2025: 1 descendant cleared2015: 1 descendant cleared1990200020102020
  1. This deviceK924165 Optisol-GS Corneal Storage MediaChiron Intraoptics · 1992
  2. Descendant · cites it directly · 1 of its ownK032422 Eusol-CAl.Chi.Mi.A · 2003
  3. Descendant · cites it directly · 0 of its ownK251320 XTRA4Al.Chi.Mi.A. S.R.L · 2025
  4. Descendant · cites it directly · 0 of its ownK221759 CornisolAurolab · 2022
  5. Descendant · cites it directly · 0 of its ownK151061 Cornea ColdEurobio · 2015
  6. Descendant · cites it directly · 0 of its ownK063304 LIFE4CNumedis, Inc. · 2007

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2003: 12007: 22015: 12022: 12025: 1
2003high 2 (2007) · low 0 (2004)2026

Most influential descendants

Showing 5 of 6 · See all
  • K032422Eusol-CAl.Chi.Mi.A · 2003 · cites it directly1descendant
  • K251320XTRA4Al.Chi.Mi.A. S.R.L · 2025 · cites it directly0descendants
  • K221759CornisolAurolab · 2022 · cites it directly0descendants
  • K151061Cornea ColdEurobio · 2015 · cites it directly0descendants
  • K063304LIFE4CNumedis, Inc. · 2007 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K924165Optisol-GS Corneal Storage MediaChiron Intraoptics1992—
+1K032422Eusol-CAl.Chi.Mi.A2003—
+1K251320XTRA4Al.Chi.Mi.A. S.R.L2025—
+1K221759CornisolAurolab2022—
+1K151061Cornea ColdEurobio2015—
+1K063304LIFE4CNumedis, Inc.2007—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200720
201510
202210
202510
FIG. 1 — Lineage of K924165, 1992–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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. #1 K251320 XTRA4score 10.0 · 1 generation · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K032422Eusol-CAl.Chi.Mi.A20031
K251320XTRA4Al.Chi.Mi.A. S.R.L20250
K221759CornisolAurolab20220
K151061Cornea ColdEurobio20150
K063304LIFE4CNumedis, Inc.20070

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, K032422 (Al.Chi.Mi.A, 2003) has gone furthest, with 1 descendant of its own.

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

2007: 22015: 12016: 12021: 12022: 12025: 1
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

2007: 12009: 12012: 42013: 52014: 12021: 1
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—01
20080—00
20090—01
20100—00
20110—00
20120—04
20130—05
20140—01
20151—00
20161—00
20170—00
20180—00
20190—00
20200—00
20211—01
20221—00
20230—00
20240—00
20251—00
20260—0—

More from Chiron Intraoptics

4 FDA decisions under this applicant name. See the company

  • K925631Phacotron Gold Multifunction Ultrasonic HandpieceChiron Intraoptics · 1993
  • K921728Dexsol Corneal Storage Media Container, ModifiedChiron Intraoptics · 1992
  • K921729Optisol Corneal Storage Media Container/ModifiedChiron Intraoptics · 1992

Recent decisions in LYX

The LYX category page

  • K251320XTRA4Al.Chi.Mi.A. S.R.L · 2025
  • K221759CornisolAurolab · 2022
  • K211786Independent Corneal Viewing Chamber (IVC-21)Bausch + Lomb, Incorporated · 2021
  • K162013Eusol-CAl.Chi.Mi.A. S.R.L · 2016
  • K151061Cornea ColdEurobio · 2015

https://510kreport.com/device/K924165 · printed Nov 6, 2026

Cite this page

510(k) Report. “K924165: Optisol-GS Corneal Storage Media.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K924165

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026