# K972248: Nellcor Puritan Bennett Gemini

- Pathway: 510(k) (Traditional)
- Applicant: Nellcor Puritan Bennett, Inc.
- Decided: Sep 12, 1997 after 88 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- 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 K950484 (1996). 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)
- K950484: Tbird VS Ventilator and Tbird Avs Ventilator, Bird Products Corp. (1996) Summary page 3.

## Indications for use
The Gemini Ventilator is intended to provide invasive or non-invasive pressure support ventilation to pediatric and adult patients requiring respiratory support. For invasive and non-invasive pressure ventilation, and non-invasive volume targeted ventilation, the patient should weigh no less than 44 pounds (20 kg). For invasive volume targeted ventilation, the patient should be at least 88 pounds (40 kg). Pediatric restrictions include those patients who require invasive ventilation using an ET4 or smaller diameter tube. The Gemini can be used in hospital and hospital-like settings such as the ICU, sub-acute care and nursing home settings. This device is intended to be used on the order, and under the supervision, of a physician.

Source page: https://510kreport.com/device/K972248
Methodology: https://510kreport.com/methodology