FDA product code JOQ: Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)
JOQ is the FDA product code for generator, pulse, pacemaker, external programmable (for electrophysiological studies only). It is a Class II device, regulated under 21 CFR 870.1750 and reviewed by the Cardiovascular panel. FDA has cleared 18 510(k) submissions under JOQ, from 12 different applicants. The average 510(k) review took 114 days (median 106). 1 PMA application cites this product code. FDA has posted 3 recalls for JOQ devices.
Classification
| Field | Value |
|---|---|
| Device name | Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only) |
| Device class | Class II |
| Regulation | 21 CFR 870.1750 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
510(k) clearances per year for JOQ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 146 |
Compare with all 510(k) review times · Search every JOQ clearance
Top JOQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medtronic Vascular | 4 | 1986-08-04 |
| Ep Medsystems | 3 | 2009-10-16 |
| Micropace Pty, Ltd. | 2 | 2007-10-26 |
| Fischer Medical | 1 | 2018-03-29 |
| St Cardio Technologies, LLC | 1 | 2007-07-02 |
7 more applicants have JOQ clearances. See the full list in Caduvo.
Most recent JOQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K173439 | Fischer Medical | Bloom2 Programmable Electrophysiology Stimulator | 2018-03-29 | 146 |
| K092913 | Ep Medsystems | EP-4TM CARDIAC STIMULATOR, MODELS: EP-04-02, EP-04-04 | 2009-10-16 | 24 |
| K072200 | Micropace Pty, Ltd. | STIMLAB | 2007-10-26 | 79 |
| K070743 | St Cardio Technologies, LLC | Z6 STIMULATOR | 2007-07-02 | 108 |
| K041442 | Ep Medsystems | EP-4 CLINICAL STIMUTATOR | 2004-09-14 | 105 |
Recalls for JOQ devices
3 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2009-03-23.
Frequently asked questions
What is FDA product code JOQ?
JOQ is the FDA product code for generator, pulse, pacemaker, external programmable (for electrophysiological studies only). It is a Class II device, regulated under 21 CFR 870.1750 and reviewed by the Cardiovascular panel.
What device class is JOQ?
Class II, regulation 21 CFR 870.1750. Typical premarket route: 510(k).
How long does a 510(k) take for product code JOQ?
Across 18 cleared submissions the average was 114 days from receipt to decision (median 106).
Which companies have the most JOQ clearances?
Medtronic Vascular (4); Ep Medsystems (3); Micropace Pty, Ltd. (2); Fischer Medical (1); St Cardio Technologies, LLC (1).
Have JOQ devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2009-03-23.
Next steps
- Run an FDA pathway report with predicate devices for product code JOQ
- Run a recall and safety report across every JOQ manufacturer
- Watch product code JOQ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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