OMNIPRO SYSTEM
FDA 510(k) clearance K050143 · decided 2005-02-01
Clearance details
- K-number
- K050143
- Device name
- OMNIPRO SYSTEM
- Applicant
- Mays and Associates, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-01-21
- Decision date
- 2005-02-01
- Days to decision
- 11 days
- Clearance type
- Traditional
- Product code
- OLV
- Device class
- 2
- Regulation number
- 882.1400
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Houston, TX, US
- Third-party review
- Yes
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Mays and Associates
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 |
|---|---|---|
| Noxturnal Web (K260585) | Nox Medical Ehf | 2026-03-20 |
| Falcon HST (K242447) | Compumedics Limited | 2025-02-20 |
| Noxturnal Web (K241288) | Nox Medical Ehf | 2024-12-23 |
| HomeSleepTest (HST, HST REM+) (K240700) | Somnomedics GmbH | 2024-12-08 |
| Cerebra Sleep System (K213007) | Cerebra Medical , Ltd. | 2022-07-06 |
| SOMNOscreen plus (K201054) | Somnomedics GmbH | 2020-08-12 |
| ApneaTrak (K192624) | Cadwell Industries, Inc. | 2020-02-20 |
| Serenity Piezo Sensor, Serenity Thermocouple Sensor (K181709) | Neurotronics, Inc. | 2018-11-16 |
| Serenity Body Position Sensor, Serenity RIP Sensors (K173868) | Neurotronics, Inc. | 2018-07-02 |
| Grass TWin (K173690) | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2018-03-09 |
| Zmachine Synergy (K172986) | Consolidated Research of Richmond, Inc. Dba General Sleep CO | 2017-12-19 |
| Comet-PLUS (K172711) | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2017-11-03 |
Recalls involving this device
No recalls on record reference this clearance.