FDA product code QNS: Low Dead Space Needle, Single Lumen, Hypodermic
QNS is the FDA product code for low dead space needle, single lumen, hypodermic. It is a Class II device, regulated under 21 CFR 880.5570 and reviewed by the General Hospital panel. FDA has cleared 3 510(k) submissions under QNS, 2 in the last five years, from 3 different applicants. The average 510(k) review took 99 days (median 30); 149 days on average over the last three years.
Definition
A low dead space single lumen hypodermic needle is a device designed to reduce medication waste. The device consists of a metal tube that is sharpened at one end and at the other end joined to connector designed to mate with a piston syringe. It may or may not have needle safety features. The device can be used by health care professions or for self-injection by the patient.
Classification
| Field | Value |
|---|---|
| Device name | Low Dead Space Needle, Single Lumen, Hypodermic |
| 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 QNS
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 1 | 0 |
| 2024 | 2 | 149 |
Compare with all 510(k) review times · Search every QNS clearance
Top QNS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ocuject, LLC | 1 | 2024-10-25 |
| Tsk Laboratory International Japan KK | 1 | 2024-03-08 |
| Poonglim Pharmatech, Inc. | 1 | 2021-02-16 |
Most recent QNS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K242956 | Ocuject, LLC | LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety Needle | 2024-10-25 | 30 |
| K231734 | Tsk Laboratory International Japan KK | STERiJECT Low Dead Space, STERiJECT The Invisible Needle | 2024-03-08 | 268 |
| K210444 | Poonglim Pharmatech, Inc. | EZ-Injec LDV Sterile Safety Needle | 2021-02-16 | 0 |
Recalls for QNS devices
openFDA lists no recalls for product code QNS.
Frequently asked questions
What is FDA product code QNS?
QNS is the FDA product code for low dead space needle, single lumen, hypodermic. It is a Class II device, regulated under 21 CFR 880.5570 and reviewed by the General Hospital panel.
What device class is QNS?
Class II, regulation 21 CFR 880.5570. Typical premarket route: 510(k).
How long does a 510(k) take for product code QNS?
Across 3 cleared submissions the average was 99 days from receipt to decision (median 30).
Which companies have the most QNS clearances?
Ocuject, LLC (1); Tsk Laboratory International Japan KK (1); Poonglim Pharmatech, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QNS
- Run a recall and safety report across every QNS manufacturer
- Watch product code QNS 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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