# K020281: Modification to Ventlab Hyperinflation Bag System

- Pathway: 510(k) (Special)
- Applicant: Ventlab Corp.
- Decided: Feb 11, 2002 after 14 days
- Product code: NHK (Resuscitator, Manual, Non Self-Inflating)
- Device class: 2
- Regulation: 21 CFR 868.5905
- Recalls of this device: none
- 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.

## Indications for use
Ventlab Corporation's Hyperinflation Bag System is a pulmonary-assist device intended to provide controlled or assisted ventilation to patients. It is designed for patients suffering from respiratory insufficiency. The system's mode of operation is to hyperventilate a patient by forcing a volume of fresh gas into the patient via compression of the reservoir bag. Typical treatment consists of hyper-inflating the patient's lung(s) over several respiration cycles. The operating clinician controls peak pressure and monitors pressure in the lungs by means of a built-in: ". manometer. Additional high pressures within the system may be controlled by use of the optional Pop-Off Valve. Federal (USA) law restricts this device to sale by or on the order of a physician.

Source page: https://510kreport.com/device/K020281
Methodology: https://510kreport.com/methodology