# K981169: Rondex CPR Iso-Shield

- Pathway: 510(k) (Traditional)
- Applicant: Rondex Products, Inc.
- Decided: May 19, 1998 after 50 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
To provide a means for a person to administer artificial ventilation using the mouth-to-mouth technique while reducing the risk of the operator's mouth coming in contact with body fluids from the non-breathing victim.

Source page: https://510kreport.com/device/K981169
Methodology: https://510kreport.com/methodology