510(k) · Cleared
ClearedBoston Advance Cleaner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Polymer Technology Corp. · MRC Products, Contact Lens Care, Rigid Gas Permeable
Cleared on Feb 19, 1998 after an 85-day review; its predicate, P890054, is listed below. 2 later devices descend from it.
- Decided
- Feb 19, 1998
- Review
- 85 days
- Class
- Class II
- Product code
- MRC
- Recalls
- None
- Predicates
- 1
1 ancestor in all. 2 later devices descend from it, 2 citing it directly.
- This deviceK974466 Boston Advance CleanerPolymer Technology Corp. · 1998
- Descendant · cites it directly · 0 of its ownK180319 Bausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston Advance…Bausch and Lomb, Incorporated · 2018
- Descendant · cites it directly · 0 of its ownK173136 Menicon Progent Protein Remover for Rigid Gas Permeable Contact LensesMenicon Co, Ltd. · 2017
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 |
|---|---|---|---|---|---|
| 0 (this device) | K974466 | Boston Advance Cleaner | Polymer Technology Corp. | 1998 | — |
| +1 | K180319 | Bausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston Advance… | Bausch and Lomb, Incorporated | 2018 | — |
| +1 | K173136 | Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses | Menicon Co, Ltd. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 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? (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 |
|---|---|---|---|
| * | P890054 | The Boston TM Cleaner II FDA lists this PMA only through its supplements; the earliest we hold is P890054/S001 (Aug 15, 1994). Summary page 3…is substantially equivalent in safety and efficacy when compared to the currently marketed Boston Advance® Cleaner (control), which was approved in May 3,1990 under PMA P890054, when used with currently marketed rigid gas permeable (RGP) contact lens materials on a daily wear basis. these lens materials i… | |
| * | — | Boston® Cleaner Named without a submission number |
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?
- Of its descendants, K180319 (Bausch and Lomb, Incorporated, 2018) has gone furthest, with 0 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 Advance ® Cleaner is indicated for use to clean fluoro silicone acrylate and silicone acrylate rigid gas permeable contact lenses after each removal and before conditioning (wetting, soaking, disinfecting).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K974466 · printed Nov 5, 2026
Cite this page
510(k) Report. “K974466: Boston Advance Cleaner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K974466
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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