FDA product code MTV: Sharps Needle Destruction Device
MTV is the FDA product code for sharps needle destruction device. It is a Class II device, regulated under 21 CFR 880.6210 and reviewed by the General Hospital panel. FDA has cleared 1 510(k) submission under MTV. The average 510(k) review took 241 days (median 241). 8 PMA applications cite this product code. FDA has posted 1 recall for MTV devices.
Definition
A prescription device that is intended to destroy needles or sharps used for medical purposes by incineration or mechanical means.
Classification
| Field | Value |
|---|---|
| Device name | Sharps Needle Destruction Device |
| Device class | Class II |
| Regulation | 21 CFR 880.6210 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
510(k) clearances per year for MTV
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 1 | 241 |
Compare with all 510(k) review times · Search every MTV clearance
Top MTV applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Needlesmart Limited | 1 | 2021-03-25 |
Most recent MTV clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K202073 | Needlesmart Limited | NeedleSmart Professional (NS Pro) | 2021-03-25 | 241 |
Recalls for MTV devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2002-08-15.
Frequently asked questions
What is FDA product code MTV?
MTV is the FDA product code for sharps needle destruction device. It is a Class II device, regulated under 21 CFR 880.6210 and reviewed by the General Hospital panel.
What device class is MTV?
Class II, regulation 21 CFR 880.6210. Typical premarket route: 510(k).
How long does a 510(k) take for product code MTV?
Across 1 cleared submissions the average was 241 days from receipt to decision (median 241).
Which companies have the most MTV clearances?
Needlesmart Limited (1).
Have MTV devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2002-08-15.
Next steps
- Run an FDA pathway report with predicate devices for product code MTV
- Run a recall and safety report across every MTV manufacturer
- Watch product code MTV 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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