510(k) · Cleared
Recalled · 2010Complete Brand Multi-Purpose Solution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Allergan, Inc. · LPN Accessories, Soft Lens Products
Cleared on Feb 20, 2002 as substantially equivalent to K003252 (Allergan, Inc., 2001) and 1 other predicate after a 61-day review. Its family tree reaches back 1 generation to 2001. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Feb 20, 2002
- Review
- 61 days
- Class
- Class II
- Product code
- LPN
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 1 generation to K003252 (2001). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K202932ABT12 multi-purpose solutionBausch & Lomb, Incorporated · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003252 | Complete Brand Multi-Purpose Solution | Allergan, Inc. | 2001 | — |
| 0 (this device) | K014202 | Complete Brand Multi-Purpose Solution | Allergan, Inc. | 2002 | — |
| +1 | K202932 | ABT12 multi-purpose solution | Bausch & Lomb, Incorporated | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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 |
|---|---|---|---|
| * | K003252 | Complete Brand Multi-Purpose SolutionSummary page 1…ially equivalent, in terms of disinfecting, cleaning, rinsing, storing and removing protein, to COMPLETE® brand Multi-Purpose Solution cleared for marketing under 510(k) K003252 and 510(k) K013479. TRADE NAME Multipurpose Solution meets the guidelines set forth in FDA's May 1, 1997 Guidancs for industry;… | 2001 |
| * | K013479 | Complete Brand Multi-Purpose Solution Cleared while this submission was under review Summary page 1…n terms of disinfecting, cleaning, rinsing, storing and removing protein, to COMPLETE® brand Multi-Purpose Solution cleared for marketing under 510(k) K003252 and 510(k) K013479. TRADE NAME Multipurpose Solution meets the guidelines set forth in FDA's May 1, 1997 Guidancs for industry; Premarket Notificat… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K202932 | ABT12 multi-purpose solution | 2021 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 23, 2010 | Not classified | Z-0129-2011 | Pending | The recall was initiated after AMO determined, through internal testing, that a limited number of the flip top caps used during production of these solutions may leak and, although unlikely, the sterility of the product may be… |
| Sep 15, 2006 | Not classified | Z-0345-2007 | Other | Due to a potential sterility issue with the product container. Three lots sold in Japan were found to have bacterial contamination, which compromised sterility. Because of this production-line issue at the firm's plant in China, AMO is… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
- Of its descendants, K202932 (Bausch & Lomb, Incorporated, 2021) 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.
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?
TRADE NAME Multi-Purpose Solution is indicated for the care of soft (hydrophilic) contact lenses. Use this product, as recommended by your eye care practitioner, to:
Chemically (NOT HEAT) Disinfect
Clean
Rinse
Store
Remove Protein
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/K014202 · printed Nov 6, 2026
Cite this page
510(k) Report. “K014202: Complete Brand Multi-Purpose Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K014202
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026