# K981905: Sterile Saline Solution 0.9%- Catalog NO, 10290, Sterile Water- Catalog NO. 10291

- Pathway: 510(k) (Traditional)
- Applicant: Acu-Pak
- Decided: Aug 18, 1998 after 78 days
- Product code: FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K922033 (1992). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922033: Saline Solution- Sterile, Trinity Laboratories, Inc. (1992) Summary page 1.
- K933526: Sterile Water, Trinity Laboratories, Inc. (1994) Summary page 1.
- (no number) 0.9% Isotonic Saline, Sterile; Sterile Water: named in the summary without a submission number

## Cited in the summary but kept off the family tree
- K405950: Sterile Saline Solution. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K111560: Wondfo Amphetamine Urine Test, Wondfo Barbiturates Urine Test, Wondfo Benzodiazepines Urine Test, Guangzhou Wondfo Biotech Co., Ltd. (2011). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
ACU-PAX Sterile Saline Solution 0.9% / Sterile Water are used in health care facilities for the irrigation of general medical devices. It is used as a lubricant for suction catheters.

Source page: https://510kreport.com/device/K981905
Methodology: https://510kreport.com/methodology