# K991785: Manual Jet Ventilator (with Regulator and Gauge), Manual Jet Ventilator (Without Regulator and Gauge), Models BE 183-Sur

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Industries, Inc.
- Decided: Aug 17, 1999 after 84 days
- Product code: BTL (Ventilator, Emergency, Powered (Resuscitator))
- Device class: 2
- Regulation: 21 CFR 868.5925
- Recalls of this device: 2 (0 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.
0 of 1 device 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.

## Recalls of this device
- Sep 7, 2012 · Class II · Z-1125-2013: Firm initiated an update to Directions for Use necessitating replacement of previously distributed Directions for Use.
- Sep 12, 2003 · Not classified · Z-0555-04: possible external debris in the on/off plunger.

## Indications for use
The BE 183-SUR and BE 183-SU Manual Jet Ventilators are designed to provide transtracheal ventilation in specific emergency situations of upper airway obstructions. These systems are used in conjunction with a transtracheal catheter, or cricothyrotomy needle, which is inserted through the cricothyroid membrane. Ventilation is accomplished by the manual, intermittent jetting of oxygen through the catheter for subsequent lung inflation.

Source page: https://510kreport.com/device/K991785
Methodology: https://510kreport.com/methodology