FDA product code QFJ: Intravascular Bleed Monitor
QFJ is the FDA product code for intravascular bleed monitor. It is a Class II device, regulated under 21 CFR 870.1345 and reviewed by the Cardiovascular panel. FDA has cleared 1 510(k) submission under QFJ, 1 in the last five years. The average 510(k) review took 114 days (median 114). 1 De Novo request was granted under it. FDA has posted 1 recall for QFJ devices, 1 initiated in the last five years.
Definition
An intravascular bleed monitor is a probe, catheter, or catheter introducer that measures changes in bioimpedance and uses an algorithm to detect or monitor progression of potential internal bleeding complications.
Classification
| Field | Value |
|---|---|
| Device name | Intravascular Bleed Monitor |
| Device class | Class II |
| Regulation | 21 CFR 870.1345 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
510(k) clearances per year for QFJ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 1 | 114 |
Compare with all 510(k) review times · Search every QFJ clearance
Top QFJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Saranas, Inc. | 1 | 2023-05-25 |
Most recent QFJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K230273 | Saranas, Inc. | Saranas Early Bird Bleed Monitoring System | 2023-05-25 | 114 |
Recalls for QFJ devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-08-10.
| Year | Recalls |
|---|---|
| 2022 | 1 |
Frequently asked questions
What is FDA product code QFJ?
QFJ is the FDA product code for intravascular bleed monitor. It is a Class II device, regulated under 21 CFR 870.1345 and reviewed by the Cardiovascular panel.
What device class is QFJ?
Class II, regulation 21 CFR 870.1345. Typical premarket route: 510(k).
How long does a 510(k) take for product code QFJ?
Across 1 cleared submissions the average was 114 days from receipt to decision (median 114).
Which companies have the most QFJ clearances?
Saranas, Inc. (1).
Have QFJ devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2022-08-10.
Next steps
- Run an FDA pathway report with predicate devices for product code QFJ
- Run a recall and safety report across every QFJ manufacturer
- Watch product code QFJ 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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