510(k) · Cleared
ClearedBausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner
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 Aug 10, 2018 as substantially equivalent to K024289 (Bausch & Lomb, Incorporated, 2003) and 1 other predicate after a 51-day review. Its family tree reaches back 2 generations to 1989. 2 later devices descend from it.
- Decided
- Aug 10, 2018
- Review
- 51 days
- Class
- Class II
- Product code
- MRC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to P850093/
- Root · 2 generations backP850093/
S003 B&L Therma-Zyme, FizzicleanBausch & Lomb, Inc. · 1989 - 1 generation backK973217 Boston Liquid Enzymatic CleanerPolymer Technology Corp. · 1997
- This deviceK181627 Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb…Bausch & Lomb, Incorporated · 2018
- Descendant · cites it directly · 0 of its ownK251876 cleadew GP hydra oneOphtecs Corporation · 2025
- Descendant · cites it directly · 0 of its ownK200416 Boston One Step Liquid Enzymatic CleanerBausch & Lomb, Incorporated · 2020
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | P850093/ | B&L Therma-Zyme, Fizziclean | Bausch & Lomb, Inc. | 1989 | — |
| −1 | K973217 | Boston Liquid Enzymatic Cleaner | Polymer Technology Corp. | 1997 | — |
| 0 (this device) | K181627 | Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb Boston One… | Bausch & Lomb, Incorporated | 2018 | — |
| +1 | K251876 | cleadew GP hydra one | Ophtecs Corporation | 2025 | — |
| +1 | K200416 | Boston One Step Liquid Enzymatic Cleaner | Bausch & Lomb, Incorporated | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2025 | 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 10.7 · 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? (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 | Decided |
|---|---|---|---|
| * | K024289 | Boston BL-1000-SIM08 Multi-Action SolutionSummary page 4….5918 Rigid Gas Permeable Contact Lens Care Products Product Code: MRC 3. Predicate Device Bausch + Lomb Boston Simplus Multi-Action Solution (K024289) Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner (K973217) 4. Description of the Device Bausch + Lomb Boston… | 2003 |
| * | K973217 | Boston Liquid Enzymatic CleanerSummary page 4…e: MRC 3. Predicate Device Bausch + Lomb Boston Simplus Multi-Action Solution (K024289) Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner (K973217) 4. Description of the Device Bausch + Lomb Boston Simplus Multi-Action Solution is a sterile, aqueous, buffered sol… | 1997 |
What descends from it? (2)
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?
- The line of descent spans 29 years and passes through 3 companies; a new generation was cleared every 20.7 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K251876 (Ophtecs Corporation, 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K024289.
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. 2018, this device’s year, is highlighted.
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?
Bausch + Lomb Boston Simplus Multi-Action Solution is indicated for cleaning, removing protein, rinsing, disinfecting, conditioning, storing and cushioning fluoro silicone acrylate and silicone acrylate rigid gas permeable contact lenses.
Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner is indicated for weekly enzymatic cleaning of fluoro silicone acrylate and silicone acrylate rigid gas permeable contact lenses during conditioning (wetting, soaking, and disinfecting) with Boston Conditioning Solution or Boston ADVANCE Comfort Formula Conditioning Solution.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181627 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181627: Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181627
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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