# K963568: Mask Surgical

- Pathway: 510(k) (Traditional)
- Applicant: The Innovative Approach, Corp.
- Decided: Feb 25, 1997 after 173 days
- Product code: FXX (Mask, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.4040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Instaguard Procedure Face Mask, Baxter: named in the summary without a submission number
- (no number) Surgine™ Face Mask, Johnson & Johnson: named in the summary without a submission number

## Indications for use
The INTENDED MEDICAL USE is to protect the healthcare personnel and patient from transfer of microorganisms, body fluids and particulate material.

Source page: https://510kreport.com/device/K963568
Methodology: https://510kreport.com/methodology