Cardiocap Monitor
FDA 510(k) K853953 · Instrumentarium Corp.
510(k) numberK853953
Submission
- Device name
- Cardiocap Monitor
- Applicant
- Instrumentarium Corp.
Wilmington, MA, US - Received
- September 25, 1985
- Decision date
- June 2, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DRT – Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2300
- Specialty
- Cardiovascular
Other 510(k)s with product code DRT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K022630 | Modification to FocusEHD · Traditional | 10/09/2002SE |
| K001729 | FocusEHD · Traditional | 07/13/2000SE |
| K001439 | Orthoceph OC100 DMUH · Traditional | 06/22/2000SE |
| K992385 | Orthopantomograph OP100DMUH · Traditional | 09/28/1999SE |
| K981641 | Mammography X-Ray Equipment Models MGF101 and MGF110, Alpha III, Alpha ST, Alpha RT and…IZH · Traditional | 07/17/1998SE |
| K962638 | Tonocap, TC-200 and Accessory CathetersCCK · Traditional | 04/04/1997SE |
| K961441 | Tonometered Slaine Blood Gas ControlJJS · Traditional | 04/30/1996SE |
| K955018 | Trip NGS & Sigmoid Catheter Phi Slide CalculatorFFT · Traditional | 01/30/1996SE |
| K934478 | Alpha StereoIZH · Traditional | 01/31/1995SE |
| K923433 | AS/3 Anaesthesia Monitoring System Airway ModuleCBQ · Traditional | 07/22/1993SE |
Questions and answers
When was Cardiocap Monitor cleared by the FDA?
Cardiocap Monitor (K853953) received a 510(k) decision of Substantially Equivalent on June 2, 1986, 250 days after the submission was received.
What is the product code of K853953?
The FDA product code is DRT – Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), a Class II (moderate risk) device regulated under 21 CFR 870.2300.