# K022062: Impact, Universal Single-Limb, Ventilator Circuit, Model 820-0099-00

- Pathway: 510(k) (Abbreviated)
- Applicant: Impact Instrumentation, Inc.
- Decided: May 6, 2003 after 315 days
- Product code: MOD (Accessory To Continuous Ventilator (Respirator))
- Device class: 2
- Regulation: 21 CFR 868.5895
- 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 K801875 (1980). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K801875: Circuits, Breathing W/Connectors, Adapt, Airlife, Inc. (1980) Summary page 1.

## Indications for use
Impact Universal Single-Limb Ventilator Circuit is intended for use in conjunction with ventilators having a single-limb circuit interface. The ventilator circuits are used as a means by which to transfer breathing gases from a ventilator to a patient (inhalation) and from a patient to atmosphere (exhalation). The device is intended for use with adults and medium to large pediatric patients.

Source page: https://510kreport.com/device/K022062
Methodology: https://510kreport.com/methodology