Hudson Rci Lifesaver Single Patient Use Manual Resuscitator
FDA 510(k) K964719 · Hudson Respiratory Care, Inc.
510(k) numberK964719
Submission
- Device name
- Hudson Rci Lifesaver Single Patient Use Manual Resuscitator
- Applicant
- Hudson Respiratory Care, Inc.
Temecula, CA, US - Received
- November 25, 1996
- Decision date
- February 21, 1997
- 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
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 |
|---|---|---|
| K031383 | Model 780BTT · Special | 07/07/2003SE |
| K011134 | Oxygen Supply Tubing, Model 1115BYX · Traditional | 06/13/2001SE |
| K011125 | Nasal Cannula, with and Without Supply Tubing, and Other Similar Nasal Cannula…CAT · Traditional | 06/13/2001SE |
| K010402 | Smooth-Flo CircuitBTT · Special | 03/14/2001SE |
| K001213 | Conchatherm 2000 Humidification System, Models 500-00, -10, -20, -30, -40, -50, & -60BTT · Traditional | 11/03/2000SE |
| K993355 | Hudson Rci Concha Column, Cat. No. 385-40 and Hudson Rci Circuit, Cat. No. 780-40…BTT · Traditional | 05/24/2000SE |
| K994352 | Side Draft Neb-U-Mist Nebulizer, Model 41896CAF · Traditional | 03/22/2000SE |
| K961150 | Dual Lumen Oxygen Delivery Gas Sampling CannulaCCK · Traditional | 09/10/1996SE |
| K961914 | Bacteria/Viral FilterCAH · Traditional | 08/14/1996SE |
| K955645 | Cath-GuideBSY · Traditional | 03/12/1996SE |
Questions and answers
When was Hudson Rci Lifesaver Single Patient Use Manual Resuscitator cleared by the FDA?
Hudson Rci Lifesaver Single Patient Use Manual Resuscitator (K964719) received a 510(k) decision of Substantially Equivalent on February 21, 1997, 88 days after the submission was received.
What is the product code of K964719?
The FDA product code is BTM – Ventilator, Emergency, Manual (Resuscitator), a Class II (moderate risk) device regulated under 21 CFR 868.5915.