FDA product code QJB: Adjunct Monitor, Protein Calorie Malnutrition
QJB is the FDA product code for adjunct monitor, protein calorie malnutrition. It is a Class II device, regulated under 21 CFR 870.2770 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 2 510(k) submissions under QJB, 1 in the last five years. The average 510(k) review took 166 days (median 166).
Definition
Device applies an alternating current of one specified frequency or more through skin-surface electrodes to estimate one or more the body composition parameters.
Classification
| Field | Value |
|---|---|
| Device name | Adjunct Monitor, Protein Calorie Malnutrition |
| Device class | Class II |
| Regulation | 21 CFR 870.2770 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
510(k) clearances per year for QJB
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 266 |
| 2023 | 1 | 66 |
Compare with all 510(k) review times · Search every QJB clearance
Top QJB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| ImpediMed Limited | 2 | 2023-05-04 |
Most recent QJB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K230531 | ImpediMed Limited | SOZO Pro | 2023-05-04 | 66 |
| K190529 | ImpediMed Limited | SOZO | 2019-11-25 | 266 |
Recalls for QJB devices
openFDA lists no recalls for product code QJB.
Frequently asked questions
What is FDA product code QJB?
QJB is the FDA product code for adjunct monitor, protein calorie malnutrition. It is a Class II device, regulated under 21 CFR 870.2770 and reviewed by the Gastroenterology and Urology panel.
What device class is QJB?
Class II, regulation 21 CFR 870.2770. Typical premarket route: 510(k).
How long does a 510(k) take for product code QJB?
Across 2 cleared submissions the average was 166 days from receipt to decision (median 166).
Which companies have the most QJB clearances?
ImpediMed Limited (2).
Next steps
- Run an FDA pathway report with predicate devices for product code QJB
- Run a recall and safety report across every QJB manufacturer
- Watch product code QJB 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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