Model 535-02 Trace-A-Pace Transmitter
FDA 510(k) K821726 · Intermedics, Inc.
510(k) numberK821726
Submission
- Device name
- Model 535-02 Trace-A-Pace Transmitter
- Applicant
- Intermedics, Inc.
Mchenry, IL, US - Received
- June 11, 1982
- Decision date
- July 8, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DXH – Transmitters And Receivers, Electrocardiograph, Telephone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2920
- Specialty
- Cardiovascular
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|---|---|---|---|
| K250233 | PreemptiveAI Clinical SDKDXH · Traditional | Measure Labs, Inc. (Dba Preemptiveai, Inc.) | 02/13/2026SE |
| K250258 | HeartBeam AIMIGo with 12-L ECG Synthesis Software SystemDXH · Traditional | Heartbeam, Inc. | 12/08/2025SE |
| K243438 | MEMO Patch M (MPT-E08R-UNC01)DXH · Traditional | Huinno Co., Ltd. | 12/05/2025SE |
| K243981 | Hexoskin Medical System (7100-00016)DXH · Traditional | Carre Technologies, Inc. | 11/18/2025SE |
| K243003 | VitalSigns 1-Lead Holter (VSH101)DXH · Traditional | VitalSigns Technology Co., Ltd. | 06/17/2025SE |
| K233521 | QT ECG (QTERD100)DXH · Special | QT Medical, Inc. | 12/06/2023SE |
| K222842 | V-Patch Cardiac MonitorDXH · Traditional | Shandong Corecare Technology Limited | 10/20/2022SE |
| K220795 | QT ECGDXH · Traditional | QT Medical, Inc. | 09/26/2022SE |
| K213357 | Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse MonitorDXH · Traditional | Verily Life Sciences, LLC | 07/19/2022SE |
| K220350 | KardiaMobile 6LDXH · Traditional | AliveCor, Inc. | 05/25/2022SE |
More from AliveCor, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K954610 | Model 430-07 Endocardial Pacing LeadDTB · Traditional | 12/16/1996PT |
| K955122 | Intermedics Model 436-07 Bipolar & Model 437-07 Unipolar Implantable Endocardial Pacing…DTB · Traditional | 11/04/1996ST |
| K962174 | Biplr Im En Pac Leads (430-07,432-03,436-02 & 07, 438-05 & 07)DTB · Traditional | 08/21/1996ST |
| K955550 | Cardifix Ez Bipolar/Unipolar Endocardial Pacing LeadDTB · Traditional | 06/19/1996ST |
| K960281 | Implantable Pacing Leads/Implantable Accessory/Non-Implantable AccessoryDTB · Traditional | 06/18/1996ST |
| K954719 | Intermedics Model 430-07 Bipolar Implantable Endocardial Pacing LeadDTB · Traditional | 02/27/1996ST |
| K933278 | Intermedics Triangle Chest Probe Model 526-04KRG · Traditional | 03/15/1995SE |
| K922042 | Cardifix Endocardial Pacing LeadDTB · Traditional | 04/29/1993SESP |
| K922972 | Models 438-05 and 435-05 Implantable Pacing LeadDTB · Traditional | 01/22/1993SESP |
| K920530 | Intermedics Model 366-15 VS 1 Header PlugDXY · Traditional | 03/17/1992SE |
Questions and answers
When was Model 535-02 Trace-A-Pace Transmitter cleared by the FDA?
Model 535-02 Trace-A-Pace Transmitter (K821726) received a 510(k) decision of Substantially Equivalent on July 8, 1982, 27 days after the submission was received.
What is the product code of K821726?
The FDA product code is DXH – Transmitters And Receivers, Electrocardiograph, Telephone, a Class II (moderate risk) device regulated under 21 CFR 870.2920.