Micropaq, Models 402 and 404
FDA 510(k) K002725 · Protocol Systems, Inc.
510(k) numberK002725
Submission
- Device name
- Micropaq, Models 402 and 404
- Applicant
- Protocol Systems, Inc.
Beaverton, OR, US - Received
- August 31, 2000
- Decision date
- November 21, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DRT – Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2300
- Specialty
- Cardiovascular
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|---|---|---|---|
| K261286 | The Circadia C300 System (C300)DRT · Special | Circadia Health, Inc. | 05/20/2026SE |
| K252676 | The Circadia C300 System (C300)DRT · Traditional | Circadia Health, Inc. | 02/03/2026SE |
| K253388 | Sleepiz One+ (Model 2.5)DRT · Special | Sleepiz AG | 01/28/2026SE |
| K251364 | Sleepiz One+ (2.5)DRT · Special | Sleepiz AG | 07/29/2025SE |
| K234003 | The Circadia C200 SystemDRT · Traditional | Circadia Technologies, Ltd. | 05/30/2024SE |
| K232354 | Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server…DRT · Traditional | Murata Vios, Inc. | 03/22/2024SE |
| K231733 | Neteera 130H-Plus Vital Sign Monitoring SensorDRT · Traditional | Neteera Technologies , Ltd. | 02/09/2024SE |
| K223163 | Sleepiz One+DRT · Traditional | Sleepiz AG | 08/18/2023SE |
| K212143 | Neteera 130H/131H Vital Sign Monitoring SensorDRT · Traditional | Neteera Technologies , Ltd. | 09/28/2022SE |
| K202138 | Cardiac Trigger MonitorDRT · Traditional | Ivy Biomedical Systems, Inc. | 05/14/2021SE |
More from Ivy Biomedical Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K972121 | Acuity Central StationMLD · Traditional | 11/07/1997SE |
| K951246 | Propaq Encore 200 Series Monitor with Neonatal Mode and Impedance Pneumography OptionsFLS · Traditional | 02/02/1996ST |
| K945071 | Propaq 200 MonitorDRT · Traditional | 05/10/1995SE |
| K935846 | Model Acuity Central StationDSI · Traditional | 12/05/1994SE |
| K934711 | Propaq ECG Telemetry OptionDRG · Traditional | 09/01/1994SE |
| K921497 | Propaq Monitors, ModificationCCK · Traditional | 03/23/1993SE |
| K914838 | Propaq 102,104,106,102EL,104EL,&106ELMHX · Traditional | 01/10/1992SE |
| K913193 | Model 100 Central StationDQK · Traditional | 10/16/1991SE |
| K910882 | Propaq 102EL, 104EL and 106ELDRT · Traditional | 05/08/1991SE |
| K910772 | Propaq 102, 104 and 106DXN · Traditional | 04/12/1991SE |
Questions and answers
When was Micropaq, Models 402 and 404 cleared by the FDA?
Micropaq, Models 402 and 404 (K002725) received a 510(k) decision of Substantially Equivalent on November 21, 2000, 82 days after the submission was received.
What is the product code of K002725?
The FDA product code is DRT – Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), a Class II (moderate risk) device regulated under 21 CFR 870.2300.