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Sodium Chloride Tablets, USP

by Akorn, Inc.

PMA P850037

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

PMA P850037↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved 1 supplement NumberP850037 Date9 Jun 1986ApprovedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Generic Name
Accessories, soft lens products
PMA Number
FDA Product Code
LPN
Device Class
Class II
Regulation
21 CFR Part 886.5928
Advisory Committee
Ophthalmic
FDA Decision
APPR Approved
PMA Supplement
S001

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is classified as Accessories, Soft Lens Products under the Ophthalmic category. Sodium Chloride Tablets, USP, are sterile tablets used to prepare isotonic saline solutions for soft contact lens care, ensuring proper hydration and storage conditions for lenses.

The tablets are supplied as a non-sterile, single-use product intended for use in ophthalmic settings. They comply with the United States Pharmacopeia (USP) standards and are regulated under FDA_PMA with PMA number P850037. Storage requires protection from moisture and light, and they are classified as Class II medical devices under 21 CFR 886.5928.

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • Are these sodium chloride tablets intended for direct application to the eye, or are they meant for preparing solutions for soft contact lens care?

    These tablets are not for direct eye application. They are designed to prepare isotonic saline solutions specifically for soft contact lens care, ensuring proper hydration and storage conditions for lenses in an ophthalmic setting.

  • Are the tablets sterile, and if so, how should they be handled to maintain sterility during use?

    The tablets themselves are sterile, but they are supplied as a non-sterile, single-use product. To maintain sterility during use, dissolve them in sterile water for irrigation or lens storage, following USP standards for isotonic saline preparation.

  • How should these tablets be stored, and what precautions should be taken to preserve their effectiveness?

    Storage requires protection from moisture and light to prevent degradation. Keep them in a cool, dry place, sealed in their original packaging until ready for use, and avoid exposing them to environmental contaminants.

  • Are these tablets reusable, or are they meant for one-time use only?

    The product is explicitly labeled as single-use, meaning each tablet should be dissolved to prepare a fresh saline solution for lens care. Reusing tablets could compromise sterility and solution quality.

  • What regulatory pathway was followed for this device, and how does that affect its use in clinical settings?

    This device was approved via the FDA Premarket Approval (PMA) pathway under PMA number P850037, classified as a Class II medical device under 21 CFR 886.5928. The approval ensures compliance with FDA standards for accessories used in soft lens care, but it does not alter the clinical indication—only that it meets regulatory requirements for use in ophthalmic settings.