Stericon Saline Solution

No FDA recalls found in the data synced 6 Oct 2026.

Generic Name

Accessories, soft lens products

PMA Number

P850070 ↗

FDA Product Code

LPN

Device Class

Class II

Regulation

21 CFR Part 886.5928

Advisory Committee

Ophthalmic

FDA Decision

APPR Approved

PMA Supplement

S002 (Normal 180 Day Track)

• Prefilled Sodium Chloride Solution for Irriga. Usp

  Class II

  FDA 510(k) K880317 Active Cleared 29 Feb 1988

• Ster Inhal Solut Prefil Btl W/Adjust Entrain Nebul

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  FDA 510(k) K901301 Active Cleared 31 May 1990

• Prefilled Respiratory Therapy Vial

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  FDA 510(k) K830943 Active Cleared 28 Apr 1983

• Prefilled Sterile Water for Inhalation, Usp

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• Tracheostomy & Nasal Suctioning Kit, 3C-Tns-1

  Class I

  FDA 510(k) K871692 Active Cleared 1 Jun 1987

• Respir Ther Humid Contain Sterile Water for Usp

  Class II

  FDA 510(k) K853146 Active Cleared 6 Aug 1985

See all devices from Automatic Liquid Packaging, Inc. →

• What is the Stericon Saline Solution primarily used for in clinical settings?

  The Stericon Saline Solution is specifically designed for ophthalmic use as an accessory for soft contact lens care. It helps maintain lens hydration and cleanliness during storage and handling, ensuring lenses remain safe and comfortable for patients.

• Is the Stericon Saline Solution reusable, or is it intended for single-use only?

  The Stericon Saline Solution is supplied in sterile, single-use containers. This design ensures safety and sterility, as reuse could compromise the integrity of the solution and potentially introduce contamination.

• How should the Stericon Saline Solution be stored to maintain its sterility?

  The solution must be stored under appropriate sterile conditions to preserve its integrity and safety. Since it is non-reusable and pre-packaged in sterile containers, it should remain unopened until use and kept in a clean, dry environment away from direct sunlight or extreme temperatures.

• What regulatory pathway does the Stericon Saline Solution follow, and what does this mean for its use?

  The Stericon Saline Solution is regulated under FDA Premarket Approval (PMA) with PMA number P850070, indicating it has undergone rigorous review to ensure safety and effectiveness. This approval specifically categorizes it under 21 CFR 886.5928, confirming its classification as an accessory for soft lens products in ophthalmic settings.

• Are there different sizes or models of the Stericon Saline Solution, or is it supplied in a uniform format?

  The provided data lists multiple registration numbers and FEI numbers, which typically correspond to different lot or batch identifiers rather than distinct sizes or models. However, the solution is consistently supplied in sterile, single-use containers, ensuring uniformity in packaging and sterility across all units.