Manual Jet Ventilator (with Regulator and Gauge), Manual Jet Ventilator (Without Regulator and Gauge), Models Be 183-SUR
FDA 510(k) K991785 · Instrumentation Industries, Inc.
510(k) numberK991785
Submission
- Device name
- Manual Jet Ventilator (with Regulator and Gauge), Manual Jet Ventilator (Without Regulator and Gauge), Models Be 183-SUR
- Applicant
- Instrumentation Industries, Inc.
Bethel Park, PA, US - Received
- May 25, 1999
- Decision date
- August 17, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- BTL – Ventilator, Emergency, Powered (Resuscitator)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5925
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
Other 510(k)s with product code BTL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K242769 | VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031)BTL · Traditional | Draegerwerk AG & CO Kgaa | 04/04/2025SE |
| K221634 | Oxymag - Transport and Emergency VentilatorBTL · Traditional | Magnamed Tecnologia Medica S/A | 05/24/2023SE |
| K202219 | VORTRAN GO2VENT with PEEP ValveBTL · Traditional | Vortran Medical Technology 1, Inc. | 02/11/2021SE |
| K193191 | MEDUMAT Easy CPR, MEDUMAT Easy CPR with bagBTL · Traditional | Weinmann Emergency Medical Technology GmbH + Co.… | 11/20/2020SE |
| K182956 | Puffin Lite Infant Resuscitation SystemBTL · Special | International Biomedical | 01/18/2019SE |
| K173373 | SafeT T-Piece ResuscitatorBTL · Traditional | Ventlab, LLC | 11/16/2018SE |
| K161420 | Moves SLCBTL · Traditional | Thornhill Research, Inc. | 06/06/2017SE |
| K162968 | Vortran GO2VENTBTL · Traditional | Vortran Medical Technology 1, Inc. | 04/10/2017SE |
| K141595 | O-Two E700,O-TWO E600,O-TWO E500BTL · Traditional | O-Two Medical Technologies, Inc. | 03/16/2015SE |
| K142096 | T-Piece ResuscitatorBTL · Traditional | Mercury Medical | 10/17/2014SE |
More from Mercury Medical
| 510(k) | Device | Decision |
|---|---|---|
| K180510 | NS 120P-TRS Airway Pressure GaugeCAP · Traditional | 05/01/2019SE |
| K162753 | RTC 26-C Inline Aerosol AdapterCAF · Traditional | 02/28/2017SE |
| K113644 | Pilot Tube Repair KitBSK · Special | 01/26/2012SE |
| K102127 | Endotracheal Tube ChangersLNZ · Special | 08/27/2010SE |
| K101857 | RTC-24 VP Metered Dose Inhaler Adapter, Model RTC 24-VCAF · Special | 07/22/2010SE |
| K091111 | RTC Metered Dose Inhaler Adapters-Single Patient Use, Model RTC 24-V, RTC Mdi Adapter…CAF · Traditional | 12/02/2009SE |
| K081778 | NS Series Vacuum/Pressure Gauges, Cuff Pressure MonitorsCAP · Traditional | 09/12/2008SE |
| K081693 | NS Series Nif (Negative Inspiratory Force) MetersBXR · Traditional | 09/11/2008SE |
| K991355 | Metered Dose Inhaler Adapter-Disposable, Adapter ReusableCAF · Traditional | 01/27/2000SE |
| K992670 | Oxygen Enrichment Kit, Models SG 066, SG 067CBK · Traditional | 09/17/1999ST |
Questions and answers
When was Manual Jet Ventilator (with Regulator and Gauge), Manual Jet Ventilator (Without Regulator and Gauge), Models Be 183-SUR cleared by the FDA?
Manual Jet Ventilator (with Regulator and Gauge), Manual Jet Ventilator (Without Regulator and Gauge), Models Be 183-SUR (K991785) received a 510(k) decision of Substantially Equivalent on August 17, 1999, 84 days after the submission was received.
What is the product code of K991785?
The FDA product code is BTL – Ventilator, Emergency, Powered (Resuscitator), a Class II (moderate risk) device regulated under 21 CFR 868.5925.