FDA product code PJT: Continuous Glucose Monitor Secondary Display
PJT is the FDA product code for continuous glucose monitor secondary display. It is a Class II device, regulated under 21 CFR 862.1350 and reviewed by the Clinical Chemistry panel. FDA has cleared 1 510(k) submission under PJT. The average 510(k) review took 8 days (median 8). 1 De Novo request was granted under it.
Definition
The purpose of the continuous glucose monitor secondary display is to notify another person, the follower, of the patient's continuous glucose monitoring system sensor glucose information in real time. The secondary display is intended for providing secondary notification of a continuous glucose monitoring system and does not replace primary real time continuous glucose monitoring or standard home blood glucose monitoring
Classification
| Field | Value |
|---|---|
| Device name | Continuous Glucose Monitor Secondary Display |
| Device class | Class II |
| Regulation | 21 CFR 862.1350 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every PJT clearance
Top PJT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medtronic Minimed, Inc. | 1 | 2015-05-19 |
Most recent PJT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K151236 | Medtronic Minimed, Inc. | MiniMed Connect kit, MiniMed Connect uploader, MiniMed Connect app, CareLink Connect (CareLink Personal) | 2015-05-19 | 8 |
Recalls for PJT devices
openFDA lists no recalls for product code PJT.
Frequently asked questions
What is FDA product code PJT?
PJT is the FDA product code for continuous glucose monitor secondary display. It is a Class II device, regulated under 21 CFR 862.1350 and reviewed by the Clinical Chemistry panel.
What device class is PJT?
Class II, regulation 21 CFR 862.1350. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code PJT?
Across 1 cleared submissions the average was 8 days from receipt to decision (median 8).
Which companies have the most PJT clearances?
Medtronic Minimed, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PJT
- Run a recall and safety report across every PJT manufacturer
- Watch product code PJT 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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