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Sterile Saline Solution 0.9% Catalog No 10290 Sterile Water Catalog No 10291

by Acu-Pak

510(k) K981905

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK981905 Date18 Aug 1998ClearedStatusActive

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  • Withdrawn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 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FOZ
Device Class
Class II
Regulation
21 CFR Part 880.5200
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 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 a sterile saline solution 0.9% and sterile water, identified by catalog numbers 10290 and 10291 respectively. It is a Class 2 general hospital device with product code FOZ, cleared through the FDA 510(k) pathway under K981905 as substantially equivalent.

The solution is used in healthcare facilities for the irrigation of general medical devices and as a lubricant for suction catheters. It is supplied sterile, intended for single-use, and stored under standard conditions as indicated by its labeling and clearance documentation.

Questions

AI-generated answers, 24 Sep 2026

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

  • What is the purpose of Acu-Pak's sterile saline solution?

    The sterile saline solution 0.9% is used in healthcare facilities for irrigation of general medical devices and as a lubricant for suction catheters. It is designed for single-use applications in clinical settings.

  • How is the sterile saline solution supplied and stored?

    The solution is supplied sterile and intended for single-use only. It should be stored under standard conditions as indicated by the product labeling and clearance documentation. The catalog number 10290 identifies the saline solution version.

  • What is the regulatory status of this product?

    This device is a Class 2 general hospital device with product code FOZ, cleared through the FDA 510(k) pathway under K981905 as substantially equivalent. It is not approved but cleared as substantially equivalent to predicate devices.

  • Is this product reusable or single-use?

    The sterile saline solution is intended for single-use only. It should not be reused or resterilized after initial use to maintain sterility and prevent potential contamination or infection risks.