AutoPulse NXT Resuscitation System
FDA 510(k) clearance K221700 · decided 2023-03-09
Clearance details
- K-number
- K221700
- Device name
- AutoPulse NXT Resuscitation System
- Applicant
- Zoll Circulation, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-06-13
- Decision date
- 2023-03-09
- Days to decision
- 269 days
- Clearance type
- Traditional
- Product code
- DRM
- Device class
- 2
- Regulation number
- 870.5200
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- San Jose, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Zoll Circulation
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| RMU-2000 Automated Chest Compression System (K211289) | Defibtech, LLC | 2021-11-09 |
| LUCAS 3 Chest Compression System (K173553) | Jolife AB | 2018-02-08 |
| LUCAS 3 Chest Compression System (K161768) | Jolife AB | 2016-11-09 |
| ROSC-U Mini Chest Compressor (RMCC) (K153628) | Resuscitation International, LLC | 2016-01-30 |
| RMU-1000 AUTOMATED CHEST COMPRESSION SYSTEM (K141809) | Defibtech, LLC | 2014-10-27 |
| AUTOPULSE RESUSCITATION SYSTEM MODEL 1000 (K112998) | Zoll Circulation | 2012-03-15 |
| MINIATURIZE CHEST COMPRESSOR (MCC) (K102068) | Resuscitation International | 2010-11-16 |
| LUCAS 2 (K090422) | Jolife AB | 2009-06-17 |
| AUTOPULSE RESUSCITATION SYSTEM, MODEL 100 (K072527) | Zoll Circulation | 2008-03-19 |
| THUMPER, MODEL: 1008 (K073079) | Michigan Instruments, Inc. | 2008-02-14 |
| AUTOPULSE RESUSCITATION SYSTEM MODEL100 (K063602) | Zoll Circulation | 2006-12-21 |
| MODIFICATION TO LUCAS (K062401) | Jolife AB | 2006-09-28 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Brand Name: AutoPulse NXT Resuscitation System Product Name: AutoPulse NXT Platform Model/ recall (Z-1533-2025) | ZOLL Circulation, Inc. | 2025-04-11 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| TherOx Downstream System (P170027/S020) | Zoll Circulation, Inc. | 2025-10-29 |
| TherOx Downstream Cartridge (P170027/S019) | Zoll Circulation, Inc. | 2025-06-20 |
| TherOx Downstream System (P170027/S017) | Zoll Circulation, Inc. | 2024-12-19 |
| TherOx DownStream System (P170027/S016) | Zoll Circulation, Inc. | 2024-12-11 |
| TherOx Downstream System (P170027/S014) | Zoll Circulation, Inc. | 2024-10-03 |
| TherOx DownStream System (P170027/S015) | Zoll Circulation, Inc. | 2024-08-14 |
| TherOx Downstream System (P170027/S011) | Zoll Circulation, Inc. | 2024-06-06 |
| TherOx® DownStream® Cartridge (DSC-2) (P170027/S012) | Zoll Circulation, Inc. | 2024-06-06 |