FDA product code QNQ: Low Dead Space Piston Syringe
QNQ is the FDA product code for low dead space piston syringe. It is a Class II device, regulated under 21 CFR 880.5860 and reviewed by the General Hospital panel. FDA has cleared 12 510(k) submissions under QNQ, 11 in the last five years, from 10 different applicants. The average 510(k) review took 222 days (median 181); 156 days on average over the last three years.
Definition
A low dead space syringe is a piston syringe designed to reduce medication waste. The device consists of a calibrated hollow barrel, a moveable plunger, and may include a needle. The device can be used by health care professions or for self-injection by the patient.
Classification
| Field | Value |
|---|---|
| Device name | Low Dead Space Piston Syringe |
| Device class | Class II |
| Regulation | 21 CFR 880.5860 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
510(k) clearances per year for QNQ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 2 | 250 |
| 2023 | 2 | 532 |
| 2024 | 4 | 165 |
| 2025 | 2 | 134 |
| 2026 | 1 | 168 |
Compare with all 510(k) review times · Search every QNQ clearance
Top QNQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Poonglim Pharmatech, Inc. | 3 | 2024-05-29 |
| CMT Health PTE., Ltd. | 1 | 2026-02-19 |
| Tsk Laboratory, Japan | 1 | 2025-07-30 |
| Prosum Medical Limited | 1 | 2025-04-02 |
| Sol-Millennium Medical, Inc. | 1 | 2024-11-20 |
5 more applicants have QNQ clearances. See the full list in Caduvo.
Most recent QNQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252814 | CMT Health PTE., Ltd. | Profoject Low Dead Space Syringe /Profoject Tuberculin Syringe; Profoject Low Dead Space Syringe with Needle /Profoject Tuberculin Syringe with Needle; Profoject Low Dead Space Syringe with Permanent Needle /Profoject Tuberculin Syringe with Permanent Needle; Profoject Low Dead Space Safety Syringe /Profoject Tuberculin Safety Syringe | 2026-02-19 | 168 |
| K250127 | Tsk Laboratory, Japan | TSK Syringe | 2025-07-30 | 194 |
| K250138 | Prosum Medical Limited | Small Volume 0.2mL Syringe | 2025-04-02 | 75 |
| K242291 | Sol-Millennium Medical, Inc. | SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/o needle, SOL-M Luer Lock Syringe (Low Dead Space) w/Exchangeable Needle, SOL-CARE Luer Lock Syringe (Low Dead Space) w/Safety Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/Exchangeable Needle | 2024-11-20 | 110 |
| K232943 | Smiths Medical Asd, Inc. | Hypodermic Needle-Pro® EDGE Safety Device with Low Dead Space Syringe | 2024-05-31 | 254 |
Recalls for QNQ devices
openFDA lists no recalls for product code QNQ.
Frequently asked questions
What is FDA product code QNQ?
QNQ is the FDA product code for low dead space piston syringe. It is a Class II device, regulated under 21 CFR 880.5860 and reviewed by the General Hospital panel.
What device class is QNQ?
Class II, regulation 21 CFR 880.5860. Typical premarket route: 510(k).
How long does a 510(k) take for product code QNQ?
Across 12 cleared submissions the average was 222 days from receipt to decision (median 181).
Which companies have the most QNQ clearances?
Poonglim Pharmatech, Inc. (3); CMT Health PTE., Ltd. (1); Tsk Laboratory, Japan (1); Prosum Medical Limited (1); Sol-Millennium Medical, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QNQ
- Run a recall and safety report across every QNQ manufacturer
- Watch product code QNQ 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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