Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart D — Cardiovascular Prosthetic Devices](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices) → [21 CFR 870.3700](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/870.3700) → KRG — Programmer, Pacemaker # KRG · Programmer, Pacemaker _Cardiovascular · 21 CFR 870.3700 · Class 3_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/KRG ## Overview - **Product Code:** KRG - **Device Name:** Programmer, Pacemaker - **Regulation:** [21 CFR 870.3700](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/870.3700) - **Device Class:** 3 - **Review Panel:** [Cardiovascular](/submissions/CV) ## Identification A pacemaker programmer is a device used to noninvasively change one or more of the electrical operating characteristics of a pacemaker. ## Classification Rationale Class III (premarket approval). ## Recent Cleared Devices (20 of 25) Showing 20 most recent of 25 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K933278](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/KRG/K933278.md) | INTERMEDICS TRIANGLE CHEST PROBE MODEL 526-04 | Intermedics, Inc. | Mar 15, 1995 | SESE | | [K884522](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/KRG/K884522.md) | MODEL 5650 OPTIMATE PERSONAL PROGRAMMER | Teletronics, Inc. | Aug 25, 1989 | SESE | | [K880738](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/KRG/K880738.md) | MODEL 2331T PATIENT PROGRAMMER | Medtronic Vascular | Nov 17, 1988 | SESE | | [K882429](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/KRG/K882429.md) | MODEL 255A PROGRAMMER III, W/SOFTWARE REVI. 4004 | Tpl-Cordis, Inc. | Jul 22, 1988 | SESE | | [K864712](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/KRG/K864712.md) | MODEL 1740 PERSONAL POCKET PROGRAMMER | Telectronics, Inc. | Dec 17, 1987 | SESE | | [K871986](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/KRG/K871986.md) | MODEL 5600B PROGRAMMER, PACEMAKER | Telectronics, Inc. | Jun 24, 1987 | SESE | | [K863046](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/KRG/K863046.md) | ULTRA SOFTWARE MODULE: MODEL 2016 | Cardiac Pacemakers, Inc. | Dec 5, 1986 | SESE | | [K863045](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/KRG/K863045.md) | PROGRAMMER MODEL 2035/ELECTROGRAM CABLE MODEL 6580 | Cardiac Pacemakers, Inc. | Sep 29, 1986 | SESE | | [K860584](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/KRG/K860584.md) | SOFTWARE MODULE/2035 PROG AND ASTRA/T PULSE GEN | Cardiac Pacemakers, Inc. | Jun 6, 1986 | SESE | | [K860546](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/KRG/K860546.md) | DIALOG PROGRAMMER 700 - PROGRAM VERSION 6.37 | Pacesetter Systems | Apr 23, 1986 | SESE | | [K844484](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/KRG/K844484.md) | HEWLETT PACKARDT HP 85 W/ VITATRON PH1 PROGRAM HEA | Vitatron Medical BV | Jul 24, 1985 | SESE | | [K844485](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/KRG/K844485.md) | CERYX6, 611, CERYX 3 311 & CERYX 1 111 | Vitatron Medical BV | Apr 19, 1985 | SESE | | [K844483](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/KRG/K844483.md) | TP 1 | Vitatron Medical BV | Apr 19, 1985 | SESE | | [K842364](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/KRG/K842364.md) | HANDHELD PACEMAKER PROGRAMMER & SOFTWAR | Cardiac Pacemakers, Inc. | Sep 24, 1984 | SESE | | [K820230](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/KRG/K820230.md) | PACEMAKER PROGRAMMER 2030 | Cardiac Pacemakers, Inc. | Mar 15, 1982 | SESE | | [K812761](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/KRG/K812761.md) | FLOW-DIRECTED BALLOON THERMODILUTION | Nova Medical Specialties | Nov 2, 1981 | SESE | | [K812813](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/KRG/K812813.md) | INTERMEDICS PROGRAMMER, MODEL 522-03 | Intermedics, Inc. | Oct 27, 1981 | SESE | | [K811217](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/KRG/K811217.md) | PACEMAKER PROGRAMMER #2010 | Cardiac Pacemakers, Inc. | Jul 20, 1981 | SESE | | [K810552](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/KRG/K810552.md) | CORDIS PACEMAKER PROGRAMMERS 255A & 256A | Cordis Corp. | Mar 20, 1981 | SESE | | [K800376](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/KRG/K800376.md) | EPR-200 PROGRAMMER MODEL 010 | Biotronik Sales, Inc. | Apr 21, 1980 | SESE | ## Top Applicants - Cardiac Pacemakers, Inc. — 7 clearances - Intermedics, Inc. — 4 clearances - Cordis Corp. — 3 clearances - Vitatron Medical BV — 3 clearances - Telectronics, Inc. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/KRG](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/KRG) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com