510(k) · Cleared
ClearedAutolens Cleaning and Disinfecting Unit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Autolens, Inc. · LYL Accessories, Solution, Ultrasonic Cleaners For Lenses
Cleared on Dec 16, 2002 as substantially equivalent to K982115 (Rim-Wide Companies, Inc., 1999) and 3 other predicates after a 208-day review. Its family tree reaches back 4 generations to 1985. 1 later device descends from it.
- Decided
- Dec 16, 2002
- Review
- 208 days
- Class
- Class II
- Product code
- LYL
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to P840068 (1985). 11 ancestors in all, the oldest K852386 (1985). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backP840068 Delta Pacemaker Sys; Vigor DDD Model 950Boston Scientific · 1985
- 3 generations backK962112 New Comfort Contact Lens Care AccessoryLens Comfort, Inc. · 1996
- 2 generations backK974724 Softmate Automatic Lens Cleaning Unit, Clensatron 700 CL Automatic…Lens Comfort, Inc. · 1998
- 1 generation backK982115 Lenserver Automatic Contact Lens Cleaning AccessoryRim-Wide Companies, Inc. · 1999
- This deviceK021699 Autolens Cleaning and Disinfecting UnitAutolens, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK210300 VueSonic One Contact Lens Cleaning System, VueSonic Advance 2…Vuesonic, LLC · 2021
Most influential descendants
Showing 1 of 1 · See all- K210300VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning SystemVuesonic, LLC · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | P840068 | Delta Pacemaker Sys; Vigor DDD Model 950 | Boston Scientific | 1985 | — |
| −3 | K962112 | New Comfort Contact Lens Care Accessory | Lens Comfort, Inc. | 1996 | — |
| −2 | K974724 | Softmate Automatic Lens Cleaning Unit, Clensatron 700 CL Automatic Contact… | Lens Comfort, Inc. | 1998 | — |
| −1 | K982115 | Lenserver Automatic Contact Lens Cleaning Accessory | Rim-Wide Companies, Inc. | 1999 | — |
| 0 (this device) | K021699 | Autolens Cleaning and Disinfecting Unit | Autolens, Inc. | 2002 | — |
| +1 | K210300 | VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens… | Vuesonic, LLC | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1996 | 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 LYL? 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 LYL device
- #1 K211361 3N Contact Lenses Adjunct Cleanerscore 3.6 · 4 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K982115 | Lenserver Automatic Contact Lens Cleaning AccessorySummary page 1…comprised of the AUTOLENS@Automatic Contact Lens Cleaning Accessory and AUTOLENS@ Multipurpose Solution is substantially equivalent to the following device accessories: K982115 Lensserver Automatic Contact Lens Cleaning Accessory cleared 1113/99 K974724: Lens Comfort Contact… | 1999 |
| * | K974724 | Softmate Automatic Lens Cleaning Unit, Clensatron 700 CL Automatic Contact Lens Cleaner…Summary page 1…on is substantially equivalent to the following device accessories: K982115 Lensserver Automatic Contact Lens Cleaning Accessory cleared 1113/99 K974724: Lens Comfort Contact Lens Accessory cleared 3/2/98 K852386: “SOFT MATE@ ,Automatic Contact Lens Cleaning Unit” cle… | 1998 |
| * | K852386 | Soft Mate Automatic Contact Lens Cleaning UnitSummary page 1…K982115 Lensserver Automatic Contact Lens Cleaning Accessory cleared 1113/99 K974724: Lens Comfort Contact Lens Accessory cleared 3/2/98 K852386: “SOFT MATE@ ,Automatic Contact Lens Cleaning Unit” cleared 9/4/85 K964222: Acu-Clens Cleaning Syst… | 1985 |
| * | K964222 | Acu-Clens Cleaning System for Contact Lens CleaningSummary page 1…3/99 K974724: Lens Comfort Contact Lens Accessory cleared 3/2/98 K852386: “SOFT MATE@ ,Automatic Contact Lens Cleaning Unit” cleared 9/4/85 K964222: Acu-Clens Cleaning System for Contact Lenses- Cleared 12/20/1996 Each of these accessories was cleared in… | 1996 |
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 |
|---|---|---|---|
| K210300 | VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System | 2021 | 0 |
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 4 companies; a new generation was cleared every 3.9 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K210300 (Vuesonic, LLC, 2021) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K982115.
How does its category compare?
All LYL devicesLYL Accessories, Solution, Ultrasonic Cleaners For Lenses: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LYL
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · LYL
Too few LYL 510(k)s in any year since 2007 to give a median.
Recalls per year · LYL
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LYL
4in 2025
MAUDE reports naming product code LYL, 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 | — | 1 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 0 | — | 8 | 9 |
| 2011 | 0 | — | 1 | 10 |
| 2012 | 0 | — | 0 | 7 |
| 2013 | 0 | — | 0 | 6 |
| 2014 | 0 | — | 1 | 5 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 6 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 2 |
| 2022 | 1 | — | 0 | 3 |
| 2023 | 0 | — | 1 | 5 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 4 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The AUTOLENS B Automatic Contact Lens Cleaning Accessory is indicated for the cleaning of soft (hydrophilic), rigid gas permeable (RGP) and hard (PMMA) contact lenses when used with AUTOLENSB Multipurpose Solution. This automatic contact lens cleaning accessory cleans contact lenses without digital rubbing. The AUTOLENSB Automatic Contact Lens Cleaning Accessory may be used as a receptacle for chemical disinfection with AUTOLENSB Multipurpose Solution.…
Read the full statement (102 words)
The AUTOLENS B Automatic Contact Lens Cleaning Accessory is indicated for the cleaning of soft (hydrophilic), rigid gas permeable (RGP) and hard (PMMA) contact lenses when used with AUTOLENSB Multipurpose Solution. This automatic contact lens cleaning accessory cleans contact lenses without digital rubbing. The AUTOLENSB Automatic Contact Lens Cleaning Accessory may be used as a receptacle for chemical disinfection with AUTOLENSB Multipurpose Solution.
AUTOLENSO Multipurpose Solution is indicated for use in cleaning, rinsing, chemical (not heat) disinfecting and protein removal, storing soft (hydrophilic), rigid gas permeable (fluoro-silicone acrylate and silicone acrylate) and PMMA contact lenses as recommended by your eye care practitioner.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021699 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021699: Autolens Cleaning and Disinfecting Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021699
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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