510(k) · Cleared
ClearedBoston BL-1000-SIM08 Multi-Action Solution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bausch & Lomb, Incorporated · MRC Products, Contact Lens Care, Rigid Gas Permeable
Cleared on May 2, 2003 after a 130-day review. The FDA summary names its predicate without a number. 7 later devices descend from it.
- Decided
- May 2, 2003
- Review
- 130 days
- Class
- Class II
- Product code
- MRC
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 2 citing it directly.
- This deviceK024289 Boston BL-1000-SIM08 Multi-Action SolutionBausch & Lomb, Incorporated · 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 ownK181627 Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb…Bausch & Lomb, Incorporated · 2018
- Descendant · 2 generations on · 1 of its ownK191872 Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting SolutionMenicon Co, Ltd. · 2020
- Descendant · 3 generations on · 0 of its ownK253795 MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting SolutionMenicon Co, Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK251876 cleadew GP hydra oneOphtecs Corporation · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K142284Clear Care Plus Cleaning & Disinfectiong Solution with HydraglydeAlcon Laboratories, Inc. · 2015 · cites it directly3descendants
- K181627Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb Boston One Step Liquid…Bausch & Lomb, Incorporated · 2018 · cites it directly2descendants
- K191872Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting SolutionMenicon Co, Ltd. · 2020 · 2 generations on1descendant
- K253795MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting SolutionMenicon Co, Ltd. · 2026 · 3 generations on0descendants
- K251876cleadew GP hydra oneOphtecs Corporation · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K024289 | Boston BL-1000-SIM08 Multi-Action Solution | Bausch & Lomb, Incorporated | 2003 | — |
| +1 | K142284 | Clear Care Plus Cleaning & Disinfectiong Solution with Hydraglyde | Alcon Laboratories, Inc. | 2015 | 1 |
| +1 | K181627 | Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb Boston One… | Bausch & Lomb, Incorporated | 2018 | — |
| +2 | K191872 | Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution | Menicon Co, Ltd. | 2020 | — |
| +3 | K253795 | MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting Solution | Menicon Co, Ltd. | 2026 | — |
| +2 | K251876 | cleadew GP hydra one | Ophtecs Corporation | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
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 10.8 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 | Decided |
|---|---|---|---|
| * | — | Boston Simplicity Multi-Action Solution Named without a submission number | |
| * | — | Bausch & Lomb ReNu Multi-Purpose Solution Named without a submission number | |
| * | — | Alcon Unique pH Solution Named without a submission number |
What descends from it? (7)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 devicesMRC 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
2026 to Oct 25, outlined.
Median 510(k) review, days · MRC
51in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MRC
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MRC
72in 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?
Boston SIMPLUS Multi-Action Solution is indicated for use in cleaning, removing protein, rinsing, disinfecting, conditioning, storing and cushioning fluoro silicone acrylate and silicone acrylate rigid gas permeable contact lenses.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K024289 · printed Nov 3, 2026
Cite this page
510(k) Report. “K024289: Boston BL-1000-SIM08 Multi-Action Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K024289
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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