# K052798: Capsuls, Models 2003-PUR8C, 2004-PVC8C

- Pathway: 510(k) (Traditional)
- Applicant: Isovac Products, LLC
- Decided: Jun 6, 2006 after 246 days
- Product code: LGN (Chamber, Patient Transport 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: 1 generation back to K790657 (1979). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K790657: Stretcher Transit Isolater #122, Vickers America Medical Corp. (1979) Summary page 1.

## Most influential descendants
- K231256: Carecube Negative Pressure Isolation Chamber (2024), 0 descendants of its own
- K163223: ORCA (tm) - Operational Rescue Containment Apparatus (2017), 0 descendants of its own

## Indications for use
The CAPSULSTM (Containment and Protection System Utilizing Life Support) is a portable Patient Isolation Unit (PIU), which prevents particulate (biological and radiological) cross-contamination between the patient and the external environment; and with features that enable medical intervention to the patient via end-user supplied medical equipment. The CAPSULS is intended to be used for: * The transport and isolation of patients on aircraft, ambulances, ships, and any vehicle capable of safely transporting a patient on a standard litter, - The temporary isolation, with or without transport, of patients within hospitals or other medical facilities.

Source page: https://510kreport.com/device/K052798
Methodology: https://510kreport.com/methodology