# K112783: Manujet Iii

- Pathway: 510(k) (Traditional)
- Applicant: VBM Medizintechnik GmbH
- Decided: Dec 22, 2011 after 87 days
- Product code: BTL (Ventilator, Emergency, Powered (Resuscitator))
- Device class: 2
- Regulation: 21 CFR 868.5925
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K132759: Ventrain (2014), 0 descendants of its own

## Indications for use
Designed to provide transtracheal ventilation in specific emergency situations of upper airway obstruction, used in conjunction with a transtracheal catheter, or a cricothyrotomy needle, which is inserted through the cricothyroid membrane. Ventilation is accomplished by manual, intermittent jetting of oxygen through the catheter for subsequent lung inflation.

Source page: https://510kreport.com/device/K112783
Methodology: https://510kreport.com/methodology