FDA product code KFX: Assembly, Thigh/Knee/Shank/Ankle/Foot, External
KFX is the FDA product code for assembly, thigh/knee/shank/ankle/foot, external. It is a Class II device, regulated under 21 CFR 890.3500 and reviewed by the Physical Medicine panel. FDA has cleared 4 510(k) submissions under KFX, from 4 different applicants. The average 510(k) review took 74 days (median 60). FDA has posted 3 recalls for KFX devices.
Classification
| Field | Value |
|---|---|
| Device name | Assembly, Thigh/Knee/Shank/Ankle/Foot, External |
| Device class | Class II |
| Regulation | 21 CFR 890.3500 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KFX clearance
Top KFX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Vascutech, Inc. | 1 | 1993-07-22 |
| Ipos Luneburg | 1 | 1983-11-28 |
| Besco Financial Service | 1 | 1983-03-09 |
| American Mcgaw | 1 | 1982-12-30 |
Most recent KFX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K932184 | Vascutech, Inc. | STERILE LEMAITRE GLOW 'N TELL TAPE | 1993-07-22 | 78 |
| K833868 | Ipos Luneburg | IPOS G.L.P. SYSTEM | 1983-11-28 | 21 |
| K830285 | Besco Financial Service | REGNELL HYDRAULIC FEMORAL PROTHESIS | 1983-03-09 | 41 |
| K822240 | American Mcgaw | ETHYLENE OXIDE STERILIZ. PARAMETRIC REL. | 1982-12-30 | 156 |
Recalls for KFX devices
3 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2013-03-18.
Frequently asked questions
What is FDA product code KFX?
KFX is the FDA product code for assembly, thigh/knee/shank/ankle/foot, external. It is a Class II device, regulated under 21 CFR 890.3500 and reviewed by the Physical Medicine panel.
What device class is KFX?
Class II, regulation 21 CFR 890.3500. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KFX?
Across 4 cleared submissions the average was 74 days from receipt to decision (median 60).
Which companies have the most KFX clearances?
Vascutech, Inc. (1); Ipos Luneburg (1); Besco Financial Service (1); American Mcgaw (1).
Have KFX devices been recalled?
Yes: 3 product recalls across 2 recall events; the most recent began 2013-03-18.
Next steps
- Run an FDA pathway report with predicate devices for product code KFX
- Run a recall and safety report across every KFX manufacturer
- Watch product code KFX 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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