Cleared Traditional

K193441 - Aqua Naina Sterile Saline Solution

K193441 is an FDA 510(k) clearance for Aqua Naina Sterile Saline Solution, manufactured by Chemtex USA, Inc.. The device is a Class 2 Ophthalmic device with product code LPN cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K193441 · Chemtex USA, Inc. · Ophthalmic device
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May 2020
Decision
167d
Days
Class 2
Risk

K193441 is an FDA 510(k) clearance for the Aqua Naina Sterile Saline Solution. Classified as Accessories, Soft Lens Products (product code LPN), Class II - Special Controls.

Submitted by Chemtex USA, Inc. (Fairfield, US). The FDA issued a Cleared decision on May 26, 2020 after a review of 167 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5928 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Chemtex USA, Inc. devices

FDA 510(k) Submission Details - K193441

510(k) Number K193441 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 2019
Decision Date May 26, 2020
Days to Decision 167 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d slower than avg
Panel avg: 110d · This submission: 167d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LPN Device Classification - Class 2, Special Controls

Product Code LPN Accessories, Soft Lens Products
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5928
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Consultant

Schiff & Company, Inc.
Thomas Padula

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LPN Accessories, Soft Lens Products

All 70
Devices cleared under the same product code (LPN) and FDA review panel - the closest regulatory comparables to K193441.
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