Rondex CPR Non Rebreathing Valve #9030, Modified
FDA 510(k) K914195 · Rondex Products, Inc.
510(k) numberK914195
Submission
- Device name
- Rondex CPR Non Rebreathing Valve #9030, Modified
- Applicant
- Rondex Products, Inc.
Rockford, IL, US - Received
- September 5, 1991
- Decision date
- November 8, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K981169 | Rondex CPR Iso-ShieldCBP · Traditional | 05/19/1998SE |
| K942671 | CPR ShieldCBP · Traditional | 02/07/1995SE |
| K943761 | Non-Breathing ValveCBP · Traditional | 11/10/1994SESK |
| K921002 | Rondex Mask Models 9122/9111/9102/911102, ModifiedBTM · Traditional | 10/06/1992SE |
| K914196 | Rondex Masks Models 9015/9011/901102 ModifiedBTM · Traditional | 11/08/1991SE |
| K902299 | CPR Valve (Non-Rebreathing) Model #9030CBP · Traditional | 10/26/1990SE |
| K902298 | Oral-Nasal Mask Resuscitation and Anesthetic GasBSJ · Traditional | 08/22/1990SE |
| K881931 | Rescue Mask & CPR Valve for Mouth-To-Mask Type CPRCBP · Traditional | 07/21/1988SE |
| K881393 | Rondex Rescue MaskBSJ · Traditional | 04/25/1988SE |
| K834250 | Rescue MaskBTM · Traditional | 01/18/1984SE |
Questions and answers
When was Rondex CPR Non Rebreathing Valve #9030, Modified cleared by the FDA?
Rondex CPR Non Rebreathing Valve #9030, Modified (K914195) received a 510(k) decision of Substantially Equivalent on November 8, 1991, 64 days after the submission was received.
What is the product code of K914195?
The FDA product code is CBP – Valve, Non-Rebreathing, a Class II (moderate risk) device regulated under 21 CFR 868.5870.