FDA product code QNW: Reprocessed Bronchoscope
QNW is the FDA product code for reprocessed bronchoscope. It is a Class II device, regulated under 21 CFR 874.4680 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 2 510(k) submissions under QNW, 1 in the last five years. The average 510(k) review took 140 days (median 140). FDA has posted 1 recall for QNW devices, 1 initiated in the last five years.
Definition
Same as EOQ except reprocessed. Please see EOQ at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=EOQ Reprocessing validation data for this device type must be included in a 510(k) submission.
Classification
| Field | Value |
|---|---|
| Device name | Reprocessed Bronchoscope |
| Device class | Class II |
| Regulation | 21 CFR 874.4680 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) |
510(k) clearances per year for QNW
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 1 | 91 |
| 2023 | 1 | 190 |
Compare with all 510(k) review times · Search every QNW clearance
Top QNW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Auris Health, Inc., A Johnson and Johnson Family Company | 2 | 2023-11-28 |
Most recent QNW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K231473 | Auris Health, Inc., A Johnson and Johnson Family Company | Monarch Bronchoscope | 2023-11-28 | 190 |
| K203614 | Auris Health, Inc., A Johnson and Johnson Family Company | Monarch Bronchoscope | 2021-03-11 | 91 |
Recalls for QNW devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-10-18.
| Year | Recalls |
|---|---|
| 2025 | 1 |
Frequently asked questions
What is FDA product code QNW?
QNW is the FDA product code for reprocessed bronchoscope. It is a Class II device, regulated under 21 CFR 874.4680 and reviewed by the Ear, Nose and Throat panel.
What device class is QNW?
Class II, regulation 21 CFR 874.4680. Typical premarket route: 510(k).
How long does a 510(k) take for product code QNW?
Across 2 cleared submissions the average was 140 days from receipt to decision (median 140).
Which companies have the most QNW clearances?
Auris Health, Inc., A Johnson and Johnson Family Company (2).
Have QNW devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2025-10-18.
Next steps
- Run an FDA pathway report with predicate devices for product code QNW
- Run a recall and safety report across every QNW manufacturer
- Watch product code QNW 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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