510(k) · Cleared
ClearedBausch + Lomb Sensitive Eyes Plus Saline Solution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bausch & Lomb, Incorporated · LPN Accessories, Soft Lens Products
Cleared on Apr 11, 2017 as substantially equivalent to P800024/
- Decided
- Apr 11, 2017
- Review
- 54 days
- Class
- Class II
- Product code
- LPN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K002319 (2000). 7 ancestors in all, the oldest P800024/
- Root · 4 generations backK002319 Purilens Saline SolutionPurilens, Inc. · 2000
- 3 generations backK093367 Sterile Saline SolutionCachet Pharmaceuticals Pvt., Ltd. · 2010
- 2 generations backK110221 Eye-Cept Sterile Saline SolutionOptics Laboratory, Inc. · 2011
- 1 generation backK151768 Menicon Saline Rinse SolutionMenicon Co, Ltd. · 2015
- This deviceK170483 Bausch + Lomb Sensitive Eyes Plus Saline SolutionBausch & Lomb, Incorporated · 2017
- 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 ownK173089 Bausch + Lomb Boston Original Cleaner, Bausch + Lomb Boston Original…Bausch & Lomb, Incorporated · 2017
Most influential descendants
Showing 2 of 2 · See all- K180319Bausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston Advance Conditioning SolutionBausch and Lomb, Incorporated · 2018 · cites it directly0descendants
- K173089Bausch + Lomb Boston Original Cleaner, Bausch + Lomb Boston Original Conditioning…Bausch & Lomb, Incorporated · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K002319 | Purilens Saline Solution | Purilens, Inc. | 2000 | — |
| −3 | K093367 | Sterile Saline Solution | Cachet Pharmaceuticals Pvt., Ltd. | 2010 | — |
| −2 | K110221 | Eye-Cept Sterile Saline Solution | Optics Laboratory, Inc. | 2011 | — |
| −1 | K151768 | Menicon Saline Rinse Solution | Menicon Co, Ltd. | 2015 | — |
| 0 (this device) | K170483 | Bausch + Lomb Sensitive Eyes Plus Saline Solution | Bausch & Lomb, Incorporated | 2017 | — |
| +1 | K180319 | Bausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston Advance… | Bausch and Lomb, Incorporated | 2018 | — |
| +1 | K173089 | Bausch + Lomb Boston Original Cleaner, Bausch + Lomb Boston Original… | Bausch & Lomb, Incorporated | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 2005 | 1 | 0 |
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 LPN? 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 LPN device
- #1 K253795 MeniSept 3% Hydrogen Peroxide Cleaning &…score 12.7 · 4 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 |
|---|---|---|---|
| * | P800024/ | Bausch & Lomb Renew (R) Saline Soln. (BL-101-BEU13 A supplement to the PMA, as the summary prints it. | 1991 |
| * | K151768 | Menicon Saline Rinse SolutionSummary page 4…ts Product Code: LPN, MRC 3. Predicate Device Bausch + Lomb Sensitive Eyes Plus Saline Solution (P800024/S16) Menicon Saline Rinse Solution (K151768) 4. Description of the Device Bausch + Lomb Sensitive Eyes Plus Saline Solution is a sterile, isotonic, buffered solu… | 2015 |
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 17 years and passes through 5 companies; a new generation was cleared every 3.8 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K180319 (Bausch and Lomb, Incorporated, 2018) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LPN devicesLPN Accessories, Soft Lens Products: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · LPN
2in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · LPN
167in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LPN
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPN
40in 2025
MAUDE reports naming product code LPN, 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 | 4 | 175 | 2 | 1,151 |
| 2008 | 0 | — | 0 | 153 |
| 2009 | 1 | — | 2 | 121 |
| 2010 | 2 | — | 2 | 241 |
| 2011 | 3 | 222 | 1 | 273 |
| 2012 | 2 | — | 0 | 268 |
| 2013 | 2 | — | 0 | 84 |
| 2014 | 0 | — | 0 | 105 |
| 2015 | 2 | — | 0 | 176 |
| 2016 | 3 | 59 | 1 | 498 |
| 2017 | 1 | — | 0 | 2,666 |
| 2018 | 0 | — | 0 | 95 |
| 2019 | 2 | — | 0 | 60 |
| 2020 | 3 | 167 | 1 | 82 |
| 2021 | 2 | — | 0 | 51 |
| 2022 | 2 | — | 0 | 62 |
| 2023 | 0 | — | 0 | 84 |
| 2024 | 0 | — | 0 | 76 |
| 2025 | 0 | — | 0 | 40 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Bausch + Lomb Sensitive Eyes Plus Saline Solution is a sterile, preserved solution for rinsing soft (hydrophilic) and gas permeable contact lenses after cleaning and before lens insertion with chemical (not heat) and hydrogen peroxide systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170483 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170483: Bausch + Lomb Sensitive Eyes Plus Saline Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170483
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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