Resuscitator, Manual, Non Self-Inflating

NHK is the FDA product code for Resuscitator, Manual, Non Self-Inflating, a class II device type, regulated under 21 CFR 868.5905. FDA's definition for this code reads: "A non self-inflating manual resuscitator, also called a hyperinflation system, is a manual ventilator intended to ventilate a patient by forcing a volume of fresh gas into the patient via compression of the ventilator bag; a source of compressed breathing gas is required to inflate the bag". As of 2026-09-10, FDA records hold 10 510(k) clearances under this code, the most recent dated 2009-11-23, and no recalls.