Rondex Masks Models 9015/9011/901102 Modified
FDA 510(k) K914196 · Rondex Products, Inc.
510(k) numberK914196
Submission
- Device name
- Rondex Masks Models 9015/9011/901102 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
- BTM – Ventilator, Emergency, Manual (Resuscitator)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5915
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
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| K243861 | butterflyBVMBTM · Traditional | Compact Medical, Inc. | 04/25/2025SE |
| K221841 | EOlife®BTM · Traditional | Archeon | 03/18/2023SE |
| K212905 | Sotair DeviceBTM · Traditional | Safe Bvm Corporation | 08/18/2022SE |
| K210288 | Disposable Manual ResuscitatorBTM · Traditional | Xiamen Compower Medical Tech. Co., Ltd. | 08/26/2021SE |
| K181583 | Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator…BTM · Traditional | Flexicare Medical Limited. | 12/07/2018SE |
| K170663 | Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount…BTM · Traditional | Foremount Enterprise Co., Ltd. | 05/11/2018SE |
| K152931 | Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II…BTM · Abbreviated | Ambu A/S | 08/29/2016SE |
| K132172 | Neonatalie ResuscitatorBTM · Abbreviated | Laerdal Medical A/S | 01/15/2015SE |
| K112852 | Babi Plus Neonatal Resuscitation BagBTM · Traditional | A Plus Medical | 01/13/2012SE |
More from A Plus Medical
| 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 |
| K914195 | Rondex CPR Non Rebreathing Valve #9030, ModifiedCBP · 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 Masks Models 9015/9011/901102 Modified cleared by the FDA?
Rondex Masks Models 9015/9011/901102 Modified (K914196) 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 K914196?
The FDA product code is BTM – Ventilator, Emergency, Manual (Resuscitator), a Class II (moderate risk) device regulated under 21 CFR 868.5915.