Ventlab Hyperinflation Bag System
FDA 510(k) K013308 · Ventlab Corp.
510(k) numberK013308
Submission
- Device name
- Ventlab Hyperinflation Bag System
- Applicant
- Ventlab Corp.
Mocksville, NC, US - Received
- October 4, 2001
- Decision date
- December 20, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- NHK – Resuscitator, Manual, Non Self-Inflating
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5905
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
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.
Other 510(k)s with product code NHK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K092687 | Venti.Plus Hyperinflation Bag System with Pressure ManometerNHK · Traditional | A Plus Medical | 11/23/2009SE |
| K020281 | Modification to Ventlab Hyperinflation Bag SystemNHK · Special | Ventlab Corp. | 02/11/2002SE |
| K001714 | Mercury Medical Hyperinflation Bag System, Model 83-900-0149NHK · Traditional | Mercury Medical | 11/03/2000SE |
| K970785 | Sims Hyperinflation Bag SystemNHK · Traditional | Sims | 06/13/1997SE |
| K952214 | Sims Intertech Hyperinflation Bag SystemNHK · Traditional | Intertech Resources, Inc. | 06/08/1995SE |
| K942571 | Hyper-Inflation BagNHK · Traditional | Med-Plastics Intl., Inc. | 06/10/1994SE |
| K940255 | Hyperinflation Bag SystemNHK · Traditional | Nutec, Inc. | 02/17/1994SE |
| K894612 | Intertech Newborn Hyperinflation Bag SystemNHK · Traditional | Intertech Resources, Inc. | 09/08/1989SE |
| K813317 | Disp. Hyperinflation Bag SystemNHK · Traditional | Intec Medical, Inc. | 03/12/1982SE |
More from Intec Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K173373 | SafeT T-Piece ResuscitatorBTL · Traditional | 11/16/2018SE |
| K120118 | Ventlab Pressurechek Disosable Column ManometerCAP · Traditional | 05/24/2012SE |
| K102674 | Cuff SentryBSK · Traditional | 07/22/2011SE |
| K093617 | Ventlab 6000 Series HumidifierBTT · Traditional | 01/27/2011SE |
| K093525 | Ace/Statcheck II CO2 Indicator, Ace/Statcheck II CO2 Indicator Arm Assemby Adult…CCK · Special | 12/10/2009SE |
| K090840 | Ventlab 5000 Series Nebulizer Assembly, Cup, Cup W/ Mask, Cup W/ Fitsall Conn.CAF · Traditional | 06/25/2009SE |
| K082204 | Series Sy Disposable Electrosurgical PadODR · Traditional | 08/13/2008SE |
| K063813 | Ventlab Nasal CO2 SAMPLING/O2 Delivery CannulaCCK · Traditional | 03/26/2008SE |
| K040726 | Ventlab Nasal CPAP CannulaBZD · Traditional | 06/03/2004SE |
| K030271 | Ventlab Bacterial Filter, Model BF100CAH · Traditional | 07/07/2003SE |
Questions and answers
When was Ventlab Hyperinflation Bag System cleared by the FDA?
Ventlab Hyperinflation Bag System (K013308) received a 510(k) decision of Substantially Equivalent on December 20, 2001, 77 days after the submission was received.
What is the product code of K013308?
The FDA product code is NHK – Resuscitator, Manual, Non Self-Inflating, a Class II (moderate risk) device regulated under 21 CFR 868.5905.