FDA product code QJZ: Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure
QJZ is the FDA product code for extracorporeal system for long-term respiratory / cardiopulmonary failure. It is a Class II device, regulated under 21 CFR 870.4100 and reviewed by the Cardiovascular panel. FDA has cleared 4 510(k) submissions under QJZ, 3 in the last five years, from 2 different applicants. The average 510(k) review took 185 days (median 186); 142 days on average over the last three years. FDA has posted 2 recalls for QJZ devices, 2 initiated in the last five years.
Definition
Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure.
Classification
| Field | Value |
|---|---|
| Device name | Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure |
| Device class | Class II |
| Regulation | 21 CFR 870.4100 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
510(k) clearances per year for QJZ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 269 |
| 2024 | 2 | 186 |
| 2026 | 1 | 99 |
Compare with all 510(k) review times · Search every QJZ clearance
Top QJZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medtronic, Inc. | 2 | 2026-07-31 |
| Fresenius Medical Care Renal Therapies Group, LLC | 2 | 2024-04-15 |
Most recent QJZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261335 | Medtronic, Inc. | VitalFlow Set with Balance Biosurface | 2026-07-31 | 99 |
| K240880 | Medtronic, Inc. | VitalFlow Set with Balance Biosurface | 2024-09-12 | 164 |
| K232926 | Fresenius Medical Care Renal Therapies Group, LLC | Novalung ultimate kit (US) | 2024-04-15 | 208 |
| K191407 | Fresenius Medical Care Renal Therapies Group, LLC | Novalung System | 2020-02-21 | 269 |
Recalls for QJZ devices
2 product recalls in 2 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2024-04-08.
| Year | Recalls |
|---|---|
| 2021 | 1 |
| 2024 | 1 |
Frequently asked questions
What is FDA product code QJZ?
QJZ is the FDA product code for extracorporeal system for long-term respiratory / cardiopulmonary failure. It is a Class II device, regulated under 21 CFR 870.4100 and reviewed by the Cardiovascular panel.
What device class is QJZ?
Class II, regulation 21 CFR 870.4100. Typical premarket route: 510(k).
How long does a 510(k) take for product code QJZ?
Across 4 cleared submissions the average was 185 days from receipt to decision (median 186).
Which companies have the most QJZ clearances?
Medtronic, Inc. (2); Fresenius Medical Care Renal Therapies Group, LLC (2).
Have QJZ devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2024-04-08.
Next steps
- Run an FDA pathway report with predicate devices for product code QJZ
- Run a recall and safety report across every QJZ manufacturer
- Watch product code QJZ 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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