Irex Cardioplan
FDA 510(k) K792525 · Irex Corp.
510(k) numberK792525
Submission
- Device name
- Irex Cardioplan
- Applicant
- Irex Corp.
Mchenry, IL, US - Received
- December 6, 1979
- Decision date
- December 27, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DQK – Computer, Diagnostic, Programmable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1425
- Specialty
- Cardiovascular
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|---|---|---|---|
| K262005 | Affera Integrated Mapping SystemDQK · Special | Medtronic, Inc. | 08/21/2026SE |
| K253692 | AVVIGO+ Multi-Modality Guidance SystemDQK · Traditional | Boston Scientific | 08/21/2026SE |
| K253576 | CorVista System® with PCWP Add-OnDQK · Traditional | Analytics For Life, Inc. | 07/26/2026SE |
| K262006 | EnSite X EP SystemDQK · Special | Abbott Medical | 07/15/2026SE |
| K252978 | ScioCardio ECG Analysis PlatformDQK · Traditional | Synergen Technology Labs, LLC | 07/09/2026SE |
| K253463 | ILR ECG Analyzer (IM007)DQK · Traditional | Implicity, Inc. | 07/02/2026SE |
| K261119 | NorthStar Mapping System (MAP01 or MAP01-01)DQK · Special | Imricor Medical Systems, Inc. | 06/30/2026SE |
| K253088 | OneStim-DUO Cardiac Stimulator (MP5003-4CO)DQK · Traditional | Micropace Pty, Ltd. | 06/12/2026SE |
| K261329 | Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter…DQK · Special | Centerline Biomedical | 06/10/2026SE |
| K252859 | ZEUS Platform (FG0501US)DQK · Traditional | iRhythm Technologies, Inc. | 05/29/2026SE |
More from iRhythm Technologies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K844404 | Irex PS, Portable Scanner and 118IYO · Traditional | 02/04/1985SE |
| K843643 | Color Doppler 880DXK · Traditional | 01/31/1985SE |
| K842408 | Irex 730 Mechanical Sector ScannerJAF · Traditional | 11/29/1984SE |
| K840139 | Irex 720 Sector ScannerIYO · Traditional | 05/09/1984SE |
| K827370 | Irex System II 2D/DOPPLER Imaging System · Traditional | 06/28/1982SE |
| K813544 | Irex 2D/DOPPLER Phase Array Imaging Sys.IYN · Traditional | 02/05/1982SE |
| K811246 | Doppler Ultrasound Blood FlowmeterDPW · Traditional | 08/12/1981SE |
| K791317 | Irex Real Time Phased Array SystemCDP · Traditional | 09/17/1979SE |
| K771372 | System IIDSF · Traditional | 08/04/1977SE |
Questions and answers
When was Irex Cardioplan cleared by the FDA?
Irex Cardioplan (K792525) received a 510(k) decision of Substantially Equivalent on December 27, 1979, 21 days after the submission was received.
What is the product code of K792525?
The FDA product code is DQK – Computer, Diagnostic, Programmable, a Class II (moderate risk) device regulated under 21 CFR 870.1425.