THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, AND MP90 INTELLIVUE PATIENT MONITORS, WITH 802.11 WIRELESS LAN
FDA 510(k) clearance K052961 · decided 2005-11-18
Clearance details
- K-number
- K052961
- Device name
- THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, AND MP90 INTELLIVUE PATIENT MONITORS, WITH 802.11 WIRELESS LAN
- Applicant
- Philips Medical Systems
- Decision
- Substantially Equivalent
- Date received
- 2005-10-21
- Decision date
- 2005-11-18
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- DRG
- Device class
- 2
- Regulation number
- 870.2910
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Andover, MA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Philips Medical Systems
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
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 |
|---|---|---|
| UbiqVue™ 2AYe Cardiac System (UX2253) (K261569) | Lifesignals, Inc. | 2026-07-09 |
| Perin Health System (PHD80060-2) (K252984) | Perin Health Devices, LLC | 2026-01-22 |
| EasyTeleMed (2.0.2) (K252440) | Ingeniars S.R.L. | 2025-10-02 |
| TeleRehab Aermos Cardiopulmonary Rehabilitation (K250259) | The ScottCare Corporation | 2025-06-04 |
| iBSM (K243837) | Iorbit Digital Technologies Private Limited | 2025-05-16 |
| UbiqVue™ 2A Multi-parameter System (UX2550) (K242018) | Lifesignals, Inc. | 2024-11-12 |
| BioButton System (K241101) | Biointellisense, Inc. | 2024-09-26 |
| ANNE Chest (K240251) | Sibel Health, Inc. | 2024-06-03 |
| ANNE One (K223711) | Sibel Health, Inc. | 2023-08-10 |
| HD+12, HD+15 (K220526) | Cardioline S.P.A | 2023-05-15 |
| Alio (K223073) | Alio, Inc. | 2023-03-17 |
| Care Team Portal (K222398) | Vivify Health, Inc. | 2023-02-06 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| HeartStart FRx Defibrillator (861304) (P180028/S019) | Philips Medical Systems | 2026-05-21 |
| HeartStart FRx Defibrillator (P180028/S018) | Philips Medical Systems | 2026-02-02 |
| HeartStart FRx Defibrillator and HeartStart SMART Pads II (P180028/S017) | Philips Medical Systems | 2025-09-05 |
| HeartStart FRx Defibrillator (861304) (P180028/S016) | Philips Medical Systems | 2025-06-09 |
| HeartStart FRx Defibrillator (P180028/S015) | Philips Medical Systems | 2025-05-09 |
| HeartStart FRx Defibrillator (861304) (P180028/S014) | Philips Medical Systems | 2024-02-21 |
| HeartStart FRx Defibrillator (P180028/S013) | Philips Medical Systems | 2023-04-03 |
| HeartStart FRx Defibrillator (P180028/S012) | Philips Medical Systems | 2022-03-20 |