510(k) · Cleared
ClearedBausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston Advance Conditioning Solution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bausch and Lomb, Incorporated · MRC Products, Contact Lens Care, Rigid Gas Permeable
Cleared on Mar 27, 2018 as substantially equivalent to K974466 (Polymer Technology Corp., 1998) and 1 other predicate after a 50-day review. Its family tree reaches back 5 generations to 2000.
- Decided
- Mar 27, 2018
- Review
- 50 days
- Class
- Class II
- Product code
- MRC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K002319 (2000). 10 ancestors in all, the oldest P800024/
- Root · 5 generations backK002319 Purilens Saline SolutionPurilens, Inc. · 2000
- 4 generations backK093367 Sterile Saline SolutionCachet Pharmaceuticals Pvt., Ltd. · 2010
- 3 generations backK110221 Eye-Cept Sterile Saline SolutionOptics Laboratory, Inc. · 2011
- 2 generations backK151768 Menicon Saline Rinse SolutionMenicon Co, Ltd. · 2015
- 1 generation backK170483 Bausch + Lomb Sensitive Eyes Plus Saline SolutionBausch & Lomb, Incorporated · 2017
- This deviceK180319 Bausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston Advance…Bausch and Lomb, Incorporated · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K002319 | Purilens Saline Solution | Purilens, Inc. | 2000 | — |
| −4 | K093367 | Sterile Saline Solution | Cachet Pharmaceuticals Pvt., Ltd. | 2010 | — |
| −3 | K110221 | Eye-Cept Sterile Saline Solution | Optics Laboratory, Inc. | 2011 | — |
| −2 | K151768 | Menicon Saline Rinse Solution | Menicon Co, Ltd. | 2015 | — |
| −1 | K170483 | Bausch + Lomb Sensitive Eyes Plus Saline Solution | Bausch & Lomb, Incorporated | 2017 | — |
| 0 (this device) | K180319 | Bausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston Advance… | Bausch and Lomb, Incorporated | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1998 | 1 | 0 |
| 2005 | 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K974466 | Boston Advance CleanerSummary page 4…: 886.5918 Rigid Gas Permeable Contact Lens Care Products Product Code: MRC 3. Predicate Device Bausch + Lomb Boston ADVANCE Cleaner (K974466) Bausch + Lomb Boston ADVANCE Conditioning Solution (P920055) Bausch + Lomb Sensitive Eyes Plus Saline Solution (K17048… | 1998 |
| Kept off the family tree | P920055 | Bausch + Lomb Boston ADVANCE Conditioning Solution Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 4…Product Code: MRC 3. Predicate Device Bausch + Lomb Boston ADVANCE Cleaner (K974466) Bausch + Lomb Boston ADVANCE Conditioning Solution (P920055) Bausch + Lomb Sensitive Eyes Plus Saline Solution (K170483) 4. Description of the Device Boston ADVANCE Cleaner is a… | |
| * | K170483 | Bausch + Lomb Sensitive Eyes Plus Saline SolutionSummary page 4…Bausch + Lomb Boston ADVANCE Cleaner (K974466) Bausch + Lomb Boston ADVANCE Conditioning Solution (P920055) Bausch + Lomb Sensitive Eyes Plus Saline Solution (K170483) 4. Description of the Device Boston ADVANCE Cleaner is a sterile, concentrated, homogeneous surfactant solution cont… | 2017 |
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 18 years and passes through 6 companies; a new generation was cleared every 1.6 years on median.
- None of the 8 ancestors has a recall.
- 1 other device also cites its predicate K974466.
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?
Boston ADVANCE Cleaner is indicated for use to clean fluoro silicone acrylate and silicone acrylate gas permeable contact lenses after each removal and before conditioning (wetting, soaking, disinfecting).
Boston ADVANCE Conditioning Solution is indicated for wetting, disinfecting and soaking (after cleaning and rinsing) fluoro silicone acrylate and silicone acrylate gas permeable contact lenses.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180319 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180319: Bausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston Advance Conditioning Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180319
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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