# K090848: Premier Sterile Saline Wound Wash, Models 210 ML, WWM

- Pathway: 510(k) (Traditional)
- Applicant: Premier Brands of America, Inc.
- Decided: Jun 17, 2009 after 79 days
- Product code: FQH (Lavage, Jet)
- Device class: 2
- Regulation: 21 CFR 880.5475
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K914579 (1992). 38 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083355: Wound Wash Saline, 210 ML, Model B8552, Wound Wash Saline, 90 ML, Model B8553, Blairex Laboratories, Inc. (2008) Summary page 2.
- K041161: Microcyn Wound Care Dressing, Oculus Innovative Sciences, Inc. (2005) Summary page 2.
- K082330: Primary Care Solutions, Inc., Sterile Water and Saline for Irrigation, Primary Care Solutions, Inc. (2008) Summary page 2.

## Most influential descendants
- K210987: IRRIGO Wound Wash Jet System (2022), 0 descendants of its own

## Indications for use
Saline Wound Wash is intended for use by or under the direction of a professional health care provider in moistening and lubricating absorbent wound dressings, cleansing and maintaining a moist wound environment for traumatic wounds such as pressure sores, leg ulcers of diabetic and vascular origin, cuts abrasions and minor bums. Saline Wound Wash is intended for use in moistening and lubricating absorbent wound dressings and for cleansing minor wounds, scrapes and minor bums. If redness, swelling or bleeding continues please seek the help of a nurse, nurses aid, doctor or other medical professional.

Source page: https://510kreport.com/device/K090848
Methodology: https://510kreport.com/methodology