# K955379: Ibc Gas Cell Components (1/2, 3/8, 1/4)

- Pathway: 510(k) (Traditional)
- Applicant: International Biophysics Corp.
- Decided: May 14, 1996 after 172 days
- Product code: DRY (Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4330
- 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) CDI Gas Cell Component (Catalog Numbers 6620, 6630 & 6640): named in the summary without a submission number

Source page: https://510kreport.com/device/K955379
Methodology: https://510kreport.com/methodology