# K942671: CPR Shield

- Pathway: 510(k) (Traditional)
- Applicant: Rondex Products, Inc.
- Decided: Feb 7, 1995 after 246 days
- Product code: CBP (Valve, Non-Rebreathing)
- Device class: 2
- Regulation: 21 CFR 868.5870
- 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) Microshield: named in the summary without a submission number
- (no number) Res-Cue Key: named in the summary without a submission number

## Indications for use
The CPR ISO-SHIELD is a device designed as an adjunct for mouth-to-mouth ventilation on a non-breathing adult or child while helping to isolate the operator’s mouth from the victim’s body fluids.

Source page: https://510kreport.com/device/K942671
Methodology: https://510kreport.com/methodology