FDA product code JOX: Analyzer, Heparin, Automated
JOX is the FDA product code for analyzer, heparin, automated. It is a Class II device, regulated under 21 CFR 864.5680 and reviewed by the Hematology panel. FDA has cleared 15 510(k) submissions under JOX, from 8 different applicants. The average 510(k) review took 68 days (median 60). FDA has posted 2 recalls for JOX devices.
Classification
| Field | Value |
|---|---|
| Device name | Analyzer, Heparin, Automated |
| Device class | Class II |
| Regulation | 21 CFR 864.5680 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every JOX clearance
Top JOX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Hemotec, Inc. | 5 | 1989-09-05 |
| Medtronic, Inc. | 3 | 2011-06-08 |
| Medtronic Vascular | 2 | 2004-12-03 |
| Medtronic Perfusion Systems | 1 | 2005-05-24 |
| Cardiovascular Diagnostics, Inc. | 1 | 2000-01-14 |
3 more applicants have JOX clearances. See the full list in Caduvo.
Most recent JOX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K111339 | Medtronic, Inc. | HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS) | 2011-06-08 | 27 |
| K102953 | Medtronic, Inc. | HEPARIN DOSE RESPONSE CARTRIDGE | 2010-11-04 | 31 |
| K101271 | Medtronic, Inc. | HEMOSTASIS MANAGEMENT SYSTEM PLUS (HMS PLUS ), MODEL 305 XX | 2010-10-13 | 160 |
| K051040 | Medtronic Perfusion Systems | HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR | 2005-05-24 | 29 |
| K043080 | Medtronic Vascular | HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR | 2004-12-03 | 25 |
Recalls for JOX devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2009-12-14.
Frequently asked questions
What is FDA product code JOX?
JOX is the FDA product code for analyzer, heparin, automated. It is a Class II device, regulated under 21 CFR 864.5680 and reviewed by the Hematology panel.
What device class is JOX?
Class II, regulation 21 CFR 864.5680. Typical premarket route: 510(k).
How long does a 510(k) take for product code JOX?
Across 15 cleared submissions the average was 68 days from receipt to decision (median 60).
Which companies have the most JOX clearances?
Hemotec, Inc. (5); Medtronic, Inc. (3); Medtronic Vascular (2); Medtronic Perfusion Systems (1); Cardiovascular Diagnostics, Inc. (1).
Have JOX devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2009-12-14.
Next steps
- Run an FDA pathway report with predicate devices for product code JOX
- Run a recall and safety report across every JOX manufacturer
- Watch product code JOX 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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