510(k) · Cleared
ClearedBoston 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 Sep 23, 2020 as substantially equivalent to K181627 (Bausch & Lomb, Incorporated, 2018) after a 216-day review. Its family tree reaches back 3 generations to 1989.
- Decided
- Sep 23, 2020
- Review
- 216 days
- Class
- Class II
- Product code
- MRC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to P850093/
- Root · 3 generations backP850093/
S003 B&L Therma-Zyme, FizzicleanBausch & Lomb, Inc. · 1989 - 2 generations backK973217 Boston Liquid Enzymatic CleanerPolymer Technology Corp. · 1997
- 1 generation backK181627 Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb…Bausch & Lomb, Incorporated · 2018
- This deviceK200416 Boston One Step Liquid Enzymatic CleanerBausch & Lomb, Incorporated · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | P850093/ | B&L Therma-Zyme, Fizziclean | Bausch & Lomb, Inc. | 1989 | — |
| −2 | K973217 | Boston Liquid Enzymatic Cleaner | Polymer Technology Corp. | 1997 | — |
| −1 | K181627 | Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb Boston One… | Bausch & Lomb, Incorporated | 2018 | — |
| 0 (this device) | 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 |
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
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 | Decided |
|---|---|---|---|
| * | K181627 | Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb Boston One Step Liquid…Summary page 4…18 Rigid Gas Permeable Contact Lens Care Product Product Code: MRC 3. Predicate Device Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner (K181627). 4. Description of the Device Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner is a preservative free steri… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
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 31 years and passes through 3 companies; a new generation was cleared every 8.2 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K181627.
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. 2020, 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 One Step Liquid Enzymatic Cleaner is indicated for weekly enzymatic cleaning of fluorosilicone 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/K200416 · printed Nov 3, 2026
Cite this page
510(k) Report. “K200416: Boston One Step Liquid Enzymatic Cleaner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K200416
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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