510(k) · Cleared
Clearedcleadew GP hydra one
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ophtecs Corporation · MRC Products, Contact Lens Care, Rigid Gas Permeable
Cleared on Oct 9, 2025 as substantially equivalent to K181627 (Bausch & Lomb, Incorporated, 2018) after a 113-day review. Its family tree reaches back 3 generations to 1989.
- Decided
- Oct 9, 2025
- Review
- 113 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 deviceK251876 cleadew GP hydra oneOphtecs Corporation · 2025
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) | K251876 | cleadew GP hydra one | Ophtecs Corporation | 2025 | — |
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 K201069 VibrantVue Scleral Salinescore 3.7 · 4 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 6…ristics to the following predicate devices: x “Boston SIMPLUS Multi-Action Solution” By Bausch + Lomb 510(k) number: K181627 Device Classification: II Product Code: MRC IV. DEVICE DESCRIPTION Ophtecs cleadew G… | 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 36 years and passes through 4 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. 2025, 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?
cleadew GP hydra one is indicated for cleaning, removing protein, rinsing, disinfecting, conditioning,
and storing fluoro silicone acrylate and silicone acrylate rigid gas permeable contact lenses.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251876 · printed Nov 4, 2026
Cite this page
510(k) Report. “K251876: cleadew GP hydra one.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K251876
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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