# K953162: Olympus High Flow Insufflation Unit

- Pathway: 510(k) (Traditional)
- Applicant: Olympus America, Inc.
- Decided: Dec 19, 1995 after 165 days
- Product code: HIF (Insufflator, Laparoscopic)
- Device class: 2
- Regulation: 21 CFR 884.1730
- Recalls of this device: 2 (2 Class I)
- 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.
1 of 1 device in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Jan 16, 2026 · Class I · Z-1353-2026: Issue with software algorithm which may lead to overpressure events.
- Jan 16, 2026 · Class I · Z-1352-2026: Issue with software algorithm which may lead to overpressure events.

Source page: https://510kreport.com/device/K953162
Methodology: https://510kreport.com/methodology