# K961454: Ammi Magni-Guard

- Pathway: 510(k) (Traditional)
- Applicant: American Medical Mfg., Inc.
- Decided: Jul 25, 1996 after 101 days
- Product code: LYU (Accessory, Surgical Apparel)
- Device class: 1
- 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) Four inch Petri-Dish: named in the summary without a submission number
- (no number) Clear Needle Counters: named in the summary without a submission number
- (no number) Face Guards: named in the summary without a submission number

## Indications for use
Magni-Guard functions in the same manner as predicate devices in that it provides protection to the surgical staff during surgical procedures.

Source page: https://510kreport.com/device/K961454
Methodology: https://510kreport.com/methodology