FDA product code QRK: Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
QRK is the FDA product code for single use only blood lancet without an integral sharps injury prevention feature. It is a Class II device, regulated under 21 CFR 878.4850 and reviewed by the General and Plastic Surgery panel. FDA has cleared 17 510(k) submissions under QRK, 17 in the last five years, from 12 different applicants. The average 510(k) review took 107 days (median 85); 77 days on average over the last three years.
Definition
A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, nonreusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.
Classification
| Field | Value |
|---|---|
| Device name | Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature |
| Device class | Class II |
| Regulation | 21 CFR 878.4850 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
510(k) clearances per year for QRK
| Year | Clearances | Avg. review days |
|---|---|---|
| 2022 | 3 | 97 |
| 2023 | 7 | 139 |
| 2024 | 3 | 88 |
| 2025 | 2 | 118 |
| 2026 | 2 | 26 |
Compare with all 510(k) review times · Search every QRK clearance
Top QRK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| SteriLance Medical (Suzhou), Inc. | 4 | 2026-08-25 |
| Stat Medical Devices | 3 | 2023-09-08 |
| Htl-Strefa S.A | 1 | 2025-07-01 |
| Ningbo Caremed Medical Products Co., Ltd. | 1 | 2024-10-28 |
| Ascensia Diabetes Care U.S., Inc. | 1 | 2024-08-15 |
7 more applicants have QRK clearances. See the full list in Caduvo.
Most recent QRK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K262631 | SteriLance Medical (Suzhou), Inc. | Disposable blood lancet (Soft Pro, Softsure, Softsure Pro, Softsense) | 2026-08-25 | 27 |
| K261634 | SteriLance Medical (Suzhou), Inc. | Disposable Blood Lancet (Soft) | 2026-06-12 | 25 |
| K250016 | Htl-Strefa S.A | droplet® personal lancets | 2025-07-01 | 179 |
| K244031 | SteriLance Medical (Suzhou), Inc. | Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposable Blood Lancet (Softsure Pro); Disposable Blood Lancet (Softsense) | 2025-02-26 | 58 |
| K242622 | Ningbo Caremed Medical Products Co., Ltd. | Sterile Lancets for Single Use | 2024-10-28 | 55 |
Recalls for QRK devices
openFDA lists no recalls for product code QRK.
Frequently asked questions
What is FDA product code QRK?
QRK is the FDA product code for single use only blood lancet without an integral sharps injury prevention feature. It is a Class II device, regulated under 21 CFR 878.4850 and reviewed by the General and Plastic Surgery panel.
What device class is QRK?
Class II, regulation 21 CFR 878.4850. Typical premarket route: 510(k).
How long does a 510(k) take for product code QRK?
Across 17 cleared submissions the average was 107 days from receipt to decision (median 85).
Which companies have the most QRK clearances?
SteriLance Medical (Suzhou), Inc. (4); Stat Medical Devices (3); Htl-Strefa S.A (1); Ningbo Caremed Medical Products Co., Ltd. (1); Ascensia Diabetes Care U.S., Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QRK
- Run a recall and safety report across every QRK manufacturer
- Watch product code QRK 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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