# K163223: ORCA (tm) - Operational Rescue Containment Apparatus

- Pathway: 510(k) (Traditional)
- Applicant: Isovac Products, LLC
- Decided: Nov 2, 2017 after 351 days
- Product code: LGM (Chamber, Patient Isolation)
- Device class: 2
- Regulation: 21 CFR 880.5450
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K790657 (1979). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052798: Capsuls, Models 2003-PUR8C, 2004-PVC8C, Isovac Products, LLC (2006) Summary page 4.

## Indications for use
The Model ORCA-2016CN is a portable and ambulatory Patient Isolation Unit (PIU) designed to prevent chemical and particulate (biological and radiological) cross-contamination between an enclosed contaminated patient and the external environment during evacuation and transport activities.

Source page: https://510kreport.com/device/K163223
Methodology: https://510kreport.com/methodology