Matrx Hope(R) 5 Resuscitator
FDA 510(k) K921982 · Matrix Medica, Inc.
510(k) numberK921982
Submission
- Device name
- Matrx Hope(R) 5 Resuscitator
- Applicant
- Matrix Medica, Inc.
Orchard Park, NY, US - Received
- April 28, 1992
- Decision date
- October 28, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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
Other 510(k)s with product code BTM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251631 | The BAG manual resuscitator and accessoriesBTM · Traditional | Laerdal Medical AS | 11/24/2025SE |
| 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 |
|---|---|---|
| K961536 | FlexscopeGDB · Traditional | 09/18/1996SE |
| K923693 | KlormanLRJ · Traditional | 01/23/1996SE |
| K915353 | Matrx Medical Maximizer 1000 and 2000 Vacuum PumpEIA · Traditional | 12/27/1991SE |
| K912661 | Matrx, Pyramid Triangle BandageILI · Traditional | 08/21/1991SE |
| K900551 | Matrx Disposable Non-Invasive Gelled Pacing Elec.DRS · Traditional | 05/09/1990SE |
| K895533 | Life Defense Plus(Tm), Defibrillator/Monitor/PacerLDD · Traditional | 01/26/1990SE |
| K895525 | Matrx Battery Charger/Defibrillator TesterDRL · Traditional | 01/26/1990SE |
| K893219 | Matrx Dental UnitEIA · Traditional | 08/07/1989SE |
| K883833 | Nitronox(R), First Response Nitronox(Tm)BZR · Traditional | 02/17/1989SE |
| K884879 | Centurion(Tm) MixerBSZ · Traditional | 02/09/1989SE |
Questions and answers
When was Matrx Hope(R) 5 Resuscitator cleared by the FDA?
Matrx Hope(R) 5 Resuscitator (K921982) received a 510(k) decision of Substantially Equivalent on October 28, 1994, 913 days after the submission was received.
What is the product code of K921982?
The FDA product code is BTM – Ventilator, Emergency, Manual (Resuscitator), a Class II (moderate risk) device regulated under 21 CFR 868.5915.