FDA product code JFC: System, Pressure Measurement, Intermittent
JFC is the FDA product code for system, pressure measurement, intermittent. It is a Class I device, regulated under 21 CFR 890.1600 and reviewed by the Physical Medicine panel. FDA has cleared 11 510(k) submissions under JFC, from 10 different applicants. The average 510(k) review took 101 days (median 85). FDA has posted 1 recall for JFC devices.
Classification
| Field | Value |
|---|---|
| Device name | System, Pressure Measurement, Intermittent |
| Device class | Class I |
| Regulation | 21 CFR 890.1600 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JFC clearance
Top JFC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Pin Dot Products, Inc. | 2 | 1993-03-09 |
| Force Sensing Systems | 1 | 1993-05-12 |
| Gabel Medical Instruments, Ltd. | 1 | 1993-03-09 |
| Wrm Computers | 1 | 1992-04-07 |
| Talley Group, Ltd. | 1 | 1991-12-19 |
5 more applicants have JFC clearances. See the full list in Caduvo.
Most recent JFC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K924705 | Force Sensing Systems | FORCE SENSING ARRAY | 1993-05-12 | 237 |
| K925052 | Gabel Medical Instruments, Ltd. | QA PRESSURE MEASUREMENT SYSTEM | 1993-03-09 | 154 |
| K925258 | Pin Dot Products, Inc. | DYNAMIC PRESSURE MONITOR 2000M AND 2000C | 1993-03-09 | 141 |
| K915278 | Wrm Computers | CDG GAIT ANALYSES SYSTEM | 1992-04-07 | 134 |
| K914776 | Talley Group, Ltd. | OXFORD PRESSURE MONITOR/TALLEY PRESSURE MONITOR | 1991-12-19 | 57 |
Recalls for JFC devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2009-07-20.
Frequently asked questions
What is FDA product code JFC?
JFC is the FDA product code for system, pressure measurement, intermittent. It is a Class I device, regulated under 21 CFR 890.1600 and reviewed by the Physical Medicine panel.
What device class is JFC?
Class I, regulation 21 CFR 890.1600. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JFC?
Across 11 cleared submissions the average was 101 days from receipt to decision (median 85).
Which companies have the most JFC clearances?
Pin Dot Products, Inc. (2); Force Sensing Systems (1); Gabel Medical Instruments, Ltd. (1); Wrm Computers (1); Talley Group, Ltd. (1).
Have JFC devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2009-07-20.
Next steps
- Run an FDA pathway report with predicate devices for product code JFC
- Run a recall and safety report across every JFC manufacturer
- Watch product code JFC 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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