FDA product code QYM: Ophthalmic Needle
QYM is the FDA product code for ophthalmic needle. It is a Class II device, regulated under 21 CFR 880.5570 and reviewed by the General Hospital panel. FDA has cleared 2 510(k) submissions under QYM, 2 in the last five years, from 2 different applicants. The average 510(k) review took 148 days (median 148); 99 days on average over the last three years.
Definition
An Ophthalmic Needle is a needle intended for intraocular injections. The device should be used by health care professionals to perform injections into the eye.
Classification
| Field | Value |
|---|---|
| Device name | Ophthalmic Needle |
| Device class | Class II |
| Regulation | 21 CFR 880.5570 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
510(k) clearances per year for QYM
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 1 | 197 |
| 2024 | 1 | 99 |
Compare with all 510(k) review times · Search every QYM clearance
Top QYM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Tsk Laboratory International Japan KK | 1 | 2024-10-23 |
| Terumo Europe N.V. | 1 | 2023-10-18 |
Most recent QYM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K242073 | Tsk Laboratory International Japan KK | STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS) | 2024-10-23 | 99 |
| K230951 | Terumo Europe N.V. | Terumo Injection Filter Needle (NF-3013RBKE05M) | 2023-10-18 | 197 |
Recalls for QYM devices
openFDA lists no recalls for product code QYM.
Frequently asked questions
What is FDA product code QYM?
QYM is the FDA product code for ophthalmic needle. It is a Class II device, regulated under 21 CFR 880.5570 and reviewed by the General Hospital panel.
What device class is QYM?
Class II, regulation 21 CFR 880.5570. Typical premarket route: 510(k).
How long does a 510(k) take for product code QYM?
Across 2 cleared submissions the average was 148 days from receipt to decision (median 148).
Which companies have the most QYM clearances?
Tsk Laboratory International Japan KK (1); Terumo Europe N.V. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QYM
- Run a recall and safety report across every QYM manufacturer
- Watch product code QYM 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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