Exhalation Valve
FDA 510(k) K984481 · Intersurgical, Inc.
510(k) numberK984481
Submission
- Device name
- Exhalation Valve
- Applicant
- Intersurgical, Inc.
Liverpool, NY, US - Received
- December 16, 1998
- Decision date
- January 29, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CBP – Valve, Non-Rebreathing
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5870
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
Other 510(k)s with product code CBP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241366 | QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV)CBP · Traditional | Dehas Medical Systems GmbH | 10/29/2024SE |
| K234053 | F&P Optiflow Flow DiverterCBP · Traditional | Fisher & Paykel Healthcare, Ltd. | 08/09/2024SE |
| K210992 | Altech® Exhalation Valve (Single Limb and Dual Limb)CBP · Traditional | Meditera Tibbi Malzeme San VE Tic AS | 12/23/2021SE |
| K192285 | CPR Face ShieldCBP · Traditional | Firstar Healthcare Company Limited (Guangzhou) | 11/25/2020SE |
| K173770 | OJR215 Pressure Relief ManifoldCBP · Traditional | Fisher & Paykel Healthcare Limited | 04/05/2019SE |
| K171961 | Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower…CBP · Traditional | Xiamen Compower Medical Tech. Co., Ltd. | 11/17/2017SE |
| K152521 | Seal Rite Non-Rebreathing ValveCBP · Traditional | The Lifeguard Store, Inc. | 06/03/2016SE |
| K142764 | KYOLING CPR Mask with Oxygen Port and Without Oxygen PortCBP · Traditional | Hangzhou Jinlin Medical Appliances Co., Ltd. | 07/09/2015SE |
| K142402 | BigEasy Non-Rebreathing ValveCBP · Traditional | 12th Man Technologies, Inc. | 03/23/2015SE |
| K132143 | Exhalation ValveCBP · Traditional | Intersurgical Incorporated | 06/04/2014SE |
More from Intersurgical Incorporated
| 510(k) | Device | Decision |
|---|---|---|
| K223258 | TNI Clear-Guard 3 angled breathing filter (1545020)CAH · Traditional | 06/15/2023SE |
| K141087 | Inter-Therm Pediatric Hmef, Intern-Therm Mini Pediatric Angled HmefCAH · Traditional | 02/12/2015SE |
| K132143 | Exhalation ValveCBP · Traditional | 06/04/2014SE |
| K121747 | Facefit and Facefit Ported Non-Invasive Ventilation MasksBZD · Traditional | 03/14/2013SE |
| K122077 | ManometerCAP · Traditional | 01/10/2013SE |
| K122075 | Disposable Gas Sampling Line with and Without In-Line FilterCCK · Traditional | 12/20/2012SE |
| K121026 | Flo-Guard Breathing FilterCAH · Traditional | 11/02/2012SE |
| K092451 | Intersurgical Inter-Therm Breathing Filter and Heat and Moisture Exchanger…CAH · Traditional | 10/29/2010SE |
| K092129 | Intersurgical Heated Wire Breathing Systems and Humidification Chambers, Model…BZE · Traditional | 05/18/2010SE |
| K092409 | Hydro-Guard Mini Breathing Filter and Heat and Moisture Exchanger and Air-Guard Clear…CAH · Traditional | 03/10/2010SE |
Questions and answers
When was Exhalation Valve cleared by the FDA?
Exhalation Valve (K984481) received a 510(k) decision of Substantially Equivalent on January 29, 1999, 44 days after the submission was received.
What is the product code of K984481?
The FDA product code is CBP – Valve, Non-Rebreathing, a Class II (moderate risk) device regulated under 21 CFR 868.5870.