510(k) Report

510(k) · Cleared

Cleared

Optimum Cleaning, Disinfecting and Storage Solution

K001964510(k) SpecialCleared Jul 18, 200021-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

Lobob Laboratories, Inc. · MRC Products, Contact Lens Care, Rigid Gas Permeable

Cleared on Jul 18, 2000 after a 21-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Jul 18, 2000
Review
21 days
Class
Class II
Product code
MRC
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2002: 1 descendant cleared200020052010201520202025
  1. This deviceK001964 Optimum Cleaning, Disinfecting and Storage SolutionLobob Laboratories, Inc. · 2000
  2. Descendant · cites it directly · 0 of its ownK014162 Modification to Optimum Cleaning, Disinfecting andLobob Laboratories, Inc. · 2002

Most influential descendants

Showing 1 of 1 · See all
  • K014162Modification to Optimum Cleaning, Disinfecting andLobob Laboratories, Inc. · 2002 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K001964Optimum Cleaning, Disinfecting and Storage SolutionLobob Laboratories, Inc.2000—
+1K014162Modification to Optimum Cleaning, Disinfecting andLobob Laboratories, Inc.2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
FIG. 1 — Lineage of K001964, 2000–2002Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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 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. #1 K251876 cleadew GP hydra onescore 10.7 · 3 generations · 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? (1)

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

NumberDeviceApplicantDecidedDescendants
K014162Modification to Optimum Cleaning, Disinfecting andLobob Laboratories, Inc.20020

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, K014162 (Lobob Laboratories, Inc., 2002) has gone furthest, with 0 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

2010: 12013: 22017: 22018: 32019: 12020: 22025: 1
2007high 3 (2018) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MRC

51in 2018

2018: 51 days median
2007high 51 (2018)2026

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

Recalls per year · MRC

1in 2021

2009: 12021: 1
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

2007: 12010: 22012: 32014: 12015: 12016: 22018: 22019: 12020: 32021: 12022: 42023: 22024: 22025: 72
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—01
20080—00
20090—10
20101—02
20110—00
20120—03
20132—00
20140—01
20150—01
20160—02
20172—00
201835102
20191—01
20202—03
20210—11
20220—04
20230—02
20240—02
20251—072
20260—0—

More from Lobob Laboratories, Inc.

10 FDA decisions under this applicant name. See the company

  • K014162Modification to Optimum Cleaning, Disinfecting andLobob Laboratories, Inc. · 2002
  • K001428Optimum Wetting and Rewetting DropLobob Laboratories, Inc. · 2000
  • K990044Lobob Universal Contact Lens CleanerLobob Laboratories, Inc. · 1999
  • P810041/S007Sof Pro-Clean Contact Lens CleanerLobob Laboratories, Inc. · 1990
  • P810041/S006Sof Pro-Clean Contact Lens CleanerLobob Laboratories, Inc. · 1988

Recent decisions in MRC

The MRC category page

  • K251876cleadew GP hydra oneOphtecs Corporation · 2025
  • K200416Boston One Step Liquid Enzymatic CleanerBausch & Lomb, Incorporated · 2020
  • K201069VibrantVue Scleral SalineDry Eye Innovations, LLC · 2020
  • K182984MaxiTears Contacts PFOmnivision AG · 2019
  • K181566NutrifillContamac, Ltd. · 20182 recalls

https://510kreport.com/device/K001964 · printed Nov 6, 2026

Cite this page

510(k) Report. “K001964: Optimum Cleaning, Disinfecting and Storage Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001964

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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