Product code NHK— Anesthesiology
DISP. HYPERINFLATION BAG SYSTEM
- Classification name
- Resuscitator, Manual, Non Self-Inflating
- Device class
- Class 2
- Regulation
- 21 CFR 868.5905
- Advisory panel
- Anesthesiology
- Total cleared
- 10
- First cleared
- Most recent
FDA classification definition
“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.”
Market context for product code NHK
FDA has cleared devices under product code NHK between 1982 and 2009, filed by 8 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2009
- 2002
- 2001
- 2000
- 1997
- 1995
- 1994
- 1989
- 1982
Top applicants under product code NHK
Recent clearances under product code NHK
- K092687 — VENTI.PLUS HYPERINFLATION BAG SYSTEM WITH PRESSURE MANOMETER
- K020281 — MODIFICATION TO VENTLAB HYPERINFLATION BAG SYSTEM
- K013308 — VENTLAB HYPERINFLATION BAG SYSTEM
- K001714 — MERCURY MEDICAL HYPERINFLATION BAG SYSTEM, MODEL 83-900-0149
- K970785 — SIMS HYPERINFLATION BAG SYSTEM
- K952214 — SIMS INTERTECH HYPERINFLATION BAG SYSTEM
- K942571 — HYPER-INFLATION BAG
- K940255 — HYPERINFLATION BAG SYSTEM
- K894612 — INTERTECH NEWBORN HYPERINFLATION BAG SYSTEM
- K813317 — DISP. HYPERINFLATION BAG SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.