510(k) Report

510(k) · Cleared

Cleared

Soft Mate Automatic Contact Lens Cleaning Unit

K852386510(k) TraditionalCleared Sep 4, 198591-day reviewClass II21 CFR 886.5928

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Barnes-Hind, Inc. · LPN Accessories, Soft Lens Products

Cleared on Sep 4, 1985 after a 91-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.

Decided
Sep 4, 1985
Review
91 days
Class
Class II
Product code
LPN
Recalls
None
Predicates
0

6 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2002: 1 descendant cleared1999: 2 descendants cleared1998: 1 descendant cleared2021: 1 descendant cleared2022: 1 descendant cleared1990200020102020
  1. This deviceK852386 Soft Mate Automatic Contact Lens Cleaning UnitBarnes-Hind, Inc. · 1985
  2. Descendant · cites it directly · 4 of its ownK974724 Softmate Automatic Lens Cleaning Unit, Clensatron 700 CL Automatic…Lens Comfort, Inc. · 1998
  3. Descendant · cites it directly · 3 of its ownK982115 Lenserver Automatic Contact Lens Cleaning AccessoryRim-Wide Companies, Inc. · 1999
  4. Descendant · cites it directly · 1 of its ownK021699 Autolens Cleaning and Disinfecting UnitAutolens, Inc. · 2002
  5. Descendant · 2 generations on · 0 of its ownK211361 3N Contact Lenses Adjunct CleanerSuzhou 3N Biological Technology Co., Ltd. · 2022
  6. Descendant · 2 generations on · 0 of its ownK210300 VueSonic One Contact Lens Cleaning System, VueSonic Advance 2…Vuesonic, LLC · 2021

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

1998: 11999: 22002: 12021: 12022: 1
1998high 2 (1999) · low 0 (2000)2026

Most influential descendants

Showing 5 of 6 · See all
  • K974724Softmate Automatic Lens Cleaning Unit, Clensatron 700 CL Automatic Contact Lens Cleaner…Lens Comfort, Inc. · 1998 · cites it directly4descendants
  • K982115Lenserver Automatic Contact Lens Cleaning AccessoryRim-Wide Companies, Inc. · 1999 · cites it directly3descendants
  • K021699Autolens Cleaning and Disinfecting UnitAutolens, Inc. · 2002 · cites it directly1descendant
  • K2113613N Contact Lenses Adjunct CleanerSuzhou 3N Biological Technology Co., Ltd. · 2022 · 2 generations on0descendants
  • K210300VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning SystemVuesonic, LLC · 2021 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K852386Soft Mate Automatic Contact Lens Cleaning UnitBarnes-Hind, Inc.1985—
+1K974724Softmate Automatic Lens Cleaning Unit, Clensatron 700 CL Automatic Contact…Lens Comfort, Inc.1998—
+1K982115Lenserver Automatic Contact Lens Cleaning AccessoryRim-Wide Companies, Inc.1999—
+1K021699Autolens Cleaning and Disinfecting UnitAutolens, Inc.2002—
+2K2113613N Contact Lenses Adjunct CleanerSuzhou 3N Biological Technology Co., Ltd.2022—
+2K210300VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens…Vuesonic, LLC2021—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
199920
200210
202110
202210
FIG. 1 — Lineage of K852386, 1985–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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. #1 K253795 MeniSept 3% Hydrogen Peroxide Cleaning &…score 12.7 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (6)

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K974724Softmate Automatic Lens Cleaning Unit, Clensatron 700 CL Automatic Contact Lens Cleaner…Lens Comfort, Inc.19984
K982115Lenserver Automatic Contact Lens Cleaning AccessoryRim-Wide Companies, Inc.19993
K021699Autolens Cleaning and Disinfecting UnitAutolens, Inc.20021
K991965Purilens System for Cleaning and Disinfecting Contact LensesPurilens, Inc.19990

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, K974724 (Lens Comfort, Inc., 1998) has gone furthest, with 4 descendants of its own.

How does its category compare?

All LPN devices

LPN Accessories, Soft Lens Products: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LPN

2in 2022

2007: 42009: 12010: 22011: 32012: 22013: 22015: 22016: 32017: 12019: 22020: 32021: 22022: 22026 (partial year): 1
2007high 4 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LPN

167in 2020

2007: 175 days median2011: 222 days median2016: 59 days median2020: 167 days median
2007high 222 (2011) · low 59 (2016)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LPN

1in 2020

2007: 22009: 22010: 22011: 12016: 12020: 1
2007high 2 (2007) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LPN

40in 2025

2007: 1,1512008: 1532009: 1212010: 2412011: 2732012: 2682013: 842014: 1052015: 1762016: 4982017: 2,6662018: 952019: 602020: 822021: 512022: 622023: 842024: 762025: 40
2007high 2,666 (2017) · low 40 (2025)2025

MAUDE reports naming product code LPN, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007417521,151
20080—0153
20091—2121
20102—2241
201132221273
20122—0268
20132—084
20140—0105
20152—0176
20163591498
20171—02,666
20180—095
20192—060
20203167182
20212—051
20222—062
20230—084
20240—076
20250—040
20261—0—

More from Barnes-Hind, Inc.

7 FDA decisions under this applicant name. See the company

  • K812135Barnes-Hind Weekly CleanerBarnes-Hind, Inc. · 1981
  • K811554Barnes-Hind Spectacle Lens CleanerBarnes-Hind, Inc. · 1981
  • K810285Barnes-Hind Rose Bengal Ophthalmic STR.Barnes-Hind, Inc. · 1981
  • K800582Barnes-Hond Hard Contact Lens Stor. CaseBarnes-Hind, Inc. · 1980
  • K791901Barnes-Hind Wetting & Soaking SolutionBarnes-Hind, Inc. · 1979

Recent decisions in LPN

The LPN category page

  • K253795MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting SolutionMenicon Co, Ltd. · 2026
  • K222541Bausch + Lomb Preservative Free Lubricating and Rewetting DropsBausch & Lomb, Incorporated · 2022
  • K221263Aqua Naina Plus Sterile Saline SolutionChemtex USA, Inc. · 2022
  • K202932ABT12 multi-purpose solutionBausch & Lomb, Incorporated · 2021
  • K210051OTE MPS 045 Multi-purpose Lens Care SolutionOte North America, LLC · 2021

https://510kreport.com/device/K852386 · printed Nov 4, 2026

Cite this page

510(k) Report. “K852386: Soft Mate Automatic Contact Lens Cleaning Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K852386

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026