# K013200: Renmed Contami-Shield Breathing Circuit Sleeve, Model 9999/01

- Pathway: 510(k) (Traditional)
- Applicant: Rennels Medical Corp.
- Decided: Dec 14, 2001 after 80 days
- Product code: CAH (Filter, Bacterial, Breathing-Circuit)
- Device class: 2
- Regulation: 21 CFR 868.5260
- 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) ARC Medical, Inc., Circuit Guard: named in the summary without a submission number

## Indications for use
The Contami-Shield™ Breathing Circuit Sleeve, indicated for use with mechanically-ventilated patients, is intended to reduce the gross external contamination of the breathing circuit during use. When used in conjunction with a bacterial/viral breathing filter, the Contami-Shield is intended to provide improved protection against contamination of the breathing circuit over a breathing filter alone. For Single Patient Use.

Source page: https://510kreport.com/device/K013200
Methodology: https://510kreport.com/methodology