Rusch Manual Resuscitator Bag
FDA 510(k) K993194 · Rusch, Inc.
510(k) numberK993194
Submission
- Device name
- Rusch Manual Resuscitator Bag
- Applicant
- Rusch, Inc.
Duluth, GA, US - Received
- September 23, 1999
- Decision date
- March 24, 2000
- 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 |
|---|---|---|
| K010420 | Rusch Mmg/O'Neil CatheterFCM · Traditional | 05/09/2001SE |
| K993528 | Rusch Emergency MaskCBP · Traditional | 05/31/2000SE |
| K980870 | Rusch Silicone Foley CatheterEZL · Traditional | 06/09/1998SE |
| K974419 | Rusch Simplastic Councill Tip CatheterEZL · Traditional | 01/27/1998SE |
| K963779 | Rusch Enteral Feeding TubeFPD · Traditional | 05/23/1997SE |
| K970021 | Rusch Suprapubic TrayKOB · Traditional | 02/07/1997SE |
| K963993 | Rusch Simplastic Foley Catheterization SetFCM · Traditional | 12/17/1996SE |
| K955564 | Rusch Ultra Tracheoflex Tracheostomy Set, Cuffed, SterileJOH · Traditional | 06/28/1996SE |
| K955495 | Rusch Reinforced Trachael Tube Cuffed, SterileBTR · Traditional | 06/27/1996SE |
| K953963 | Rusch Single Lumen Bronchial Tuvbe Set, Sterile, for Left & Right Sided Bronchial…BTS · Traditional | 11/27/1995SE |
Questions and answers
When was Rusch Manual Resuscitator Bag cleared by the FDA?
Rusch Manual Resuscitator Bag (K993194) received a 510(k) decision of Substantially Equivalent on March 24, 2000, 183 days after the submission was received.
What is the product code of K993194?
The FDA product code is BTM – Ventilator, Emergency, Manual (Resuscitator), a Class II (moderate risk) device regulated under 21 CFR 868.5915.