510(k) Report

510(k) · Cleared

Cleared

Aqua Naina Plus Sterile Saline Solution

K221263510(k) SpecialCleared Oct 12, 2022163-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

Chemtex USA, Inc. · LPN Accessories, Soft Lens Products

Cleared on Oct 12, 2022 as substantially equivalent to K193441 (Chemtex USA, Inc., 2020) and 3 other predicates after a 163-day review. Its family tree reaches back 5 generations to 2000.

Decided
Oct 12, 2022
Review
163 days
Class
Class II
Product code
LPN
Recalls
None
Predicates
4

Its longest line of descent runs back 5 generations to K002319 (2000). 9 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2020: 2 other ancestors2005: 1 other ancestorK002319 · Purilens Saline Solution · Purilens, Inc. · 2000K093367 · Sterile Saline Solution · Cachet Pharmaceuticals Pvt., Ltd. · 2010K110221 · Eye-Cept Sterile Saline Solution · Optics Laboratory, Inc. · 2011K151768 · Menicon Saline Rinse Solution · Menicon Co, Ltd. · 2015K201069 · VibrantVue Scleral Saline · Dry Eye Innovations, LLC · 202020002005201020152020
Other ancestors, by generation 1 generation back: 2 other ancestors3 generations back: 1 other ancestor K201069 · VibrantVue Scleral Saline · Dry Eye Innovations, LLC · 2020K151768 · Menicon Saline Rinse Solution · Menicon Co, Ltd. · 2015K110221 · Eye-Cept Sterile Saline Solution · Optics Laboratory, Inc. · 2011K093367 · Sterile Saline Solution · Cachet Pharmaceuticals Pvt., Ltd. · 2010K002319 · Purilens Saline Solution · Purilens, Inc. · 2000−50
  1. Root · 5 generations backK002319 Purilens Saline SolutionPurilens, Inc. · 2000
  2. 4 generations backK093367 Sterile Saline SolutionCachet Pharmaceuticals Pvt., Ltd. · 2010
  3. 3 generations backK110221 Eye-Cept Sterile Saline SolutionOptics Laboratory, Inc. · 2011
  4. 2 generations backK151768 Menicon Saline Rinse SolutionMenicon Co, Ltd. · 2015
  5. 1 generation backK201069 VibrantVue Scleral SalineDry Eye Innovations, LLC · 2020
  6. This deviceK221263 Aqua Naina Plus Sterile Saline SolutionChemtex USA, Inc. · 2022
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K002319Purilens Saline SolutionPurilens, Inc.2000—
−4K093367Sterile Saline SolutionCachet Pharmaceuticals Pvt., Ltd.2010—
−3K110221Eye-Cept Sterile Saline SolutionOptics Laboratory, Inc.2011—
−2K151768Menicon Saline Rinse SolutionMenicon Co, Ltd.2015—
−1K201069VibrantVue Scleral SalineDry Eye Innovations, LLC2020—
0 (this device)K221263Aqua Naina Plus Sterile Saline SolutionChemtex USA, Inc.2022—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200510
202020
FIG. 1 — Lineage of K221263, 2000–2022Source: 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), 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. #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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K193441Aqua Naina Sterile Saline Solution
Summary page 5
…e following predicate devices:  “Aqua Naina Sterile Saline Solution” (Primary Predicate) By Chemtex Usa, Inc. 510(k) number; K193441  "PuriLens Plus Preservative Free Saline” By The LifeStyle Company, Inc. 510(k) numbe…
Chemtex USA, Inc.2020—
*K200747PuriLens Plus Preservative Free Saline
Summary page 5
…510(k) number; K193441  "PuriLens Plus Preservative Free Saline” By The LifeStyle Company, Inc. 510(k) number; K200747  “Menicon Saline Rinse Solution” By Menicon Co., Ltd. 510(k) number; K151768…
The Lifestyle Company, Inc.2020—
*K151768Menicon Saline Rinse Solution
Summary page 5
…tyle Company, Inc. 510(k) number; K200747  “Menicon Saline Rinse Solution” By Menicon Co., Ltd. 510(k) number; K151768  “VibrantVue Scleral Saline” By Dry Eye Innovations, LLC 510(k) number; K201069 I…
Menicon Co, Ltd.2015—
*K201069VibrantVue Scleral Saline
Summary page 5
…nicon Co., Ltd. 510(k) number; K151768  “VibrantVue Scleral Saline” By Dry Eye Innovations, LLC 510(k) number; K201069 IV. DEVICE DESCRIPTION Aqua Naina Plus Sterile Saline Solution Aqua Naina Plus Sterile Saline Solution is a sterile, pr…
Dry Eye Innovations, LLC2020—

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 22 years and passes through 6 companies; a new generation was cleared every 3.8 years on median.
  • None of the 8 ancestors has a recall.

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. 2022, this device’s year, is highlighted.

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—

What is it indicated for?

Aqua Naina Plus Sterile Saline Solution The Aqua Naina Plus Sterile Saline Solution for single use is indicated for rinsing soft (hydrophilic) and rigid gas permeable (hard) contact lenses prior to lens insertion. This solution may be used as an insertion solution for large diameter (scleral) contact lenses, as a rinse for contact lens cases, and may be used as needed throughout the day to rinse contact lenses. The Aqua Naina Plus Sterile Saline Solution…

Read the full statement (152 words)

Aqua Naina Plus Sterile Saline Solution

The Aqua Naina Plus Sterile Saline Solution for single use is indicated for rinsing soft (hydrophilic) and rigid gas permeable (hard) contact lenses prior to lens insertion. This solution may be used as an insertion solution for large diameter (scleral) contact lenses, as a rinse for contact lens cases, and may be used as needed throughout the day to rinse contact lenses. The Aqua Naina Plus Sterile Saline Solution is indicated for use following proper lens disinfection as recommended by the eye care practitioner.

Aqua Naina Sterile Saline Solution

The Aqua Naina Sterile Saline Solution is indicated for rinsing soft (hydrophilic) and rigid gas permeable (hard) contact lenses prior to lens insertion and following proper lens disinfection as recommended by the eye care practitioner. The Aqua Naina Sterile Saline Solution may be used as needed throughout the day to rinse contact lenses and contact lens cases.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Chemtex USA, Inc.

2 FDA decisions under this applicant name. See the company

  • K193441Aqua Naina Sterile Saline SolutionChemtex USA, Inc. · 2020

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
  • K202932ABT12 multi-purpose solutionBausch & Lomb, Incorporated · 2021
  • K210051OTE MPS 045 Multi-purpose Lens Care SolutionOte North America, LLC · 2021
  • K193441Aqua Naina Sterile Saline SolutionChemtex USA, Inc. · 2020

https://510kreport.com/device/K221263 · printed Nov 4, 2026

Cite this page

510(k) Report. “K221263: Aqua Naina Plus Sterile Saline Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K221263

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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