FDA product code QRL: Multiple Use Blood Lancet For Single Patient Use Only
QRL is the FDA product code for multiple use blood lancet for single patient use only. It is a Class II device, regulated under 21 CFR 878.4850 and reviewed by the General and Plastic Surgery panel. FDA has cleared 27 510(k) submissions under QRL, 27 in the last five years, from 18 different applicants. The average 510(k) review took 104 days (median 88); 65 days on average over the last three years. FDA has posted 1 recall for QRL devices, 1 initiated in the last five years.
Definition
A multiple use capable blood lancet intended for use on a single patient that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.
Classification
| Field | Value |
|---|---|
| Device name | Multiple Use Blood Lancet For Single Patient Use Only |
| 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 QRL
| Year | Clearances | Avg. review days |
|---|---|---|
| 2022 | 17 | 108 |
| 2023 | 3 | 160 |
| 2024 | 2 | 76 |
| 2025 | 2 | 36 |
| 2026 | 3 | 83 |
Compare with all 510(k) review times · Search every QRL clearance
Top QRL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Tianjin Huahong Technology Co., Ltd. | 5 | 2026-08-18 |
| Facet Technologies, LLC | 3 | 2024-01-25 |
| SteriLance Medical (Suzhou), Inc. | 2 | 2026-07-06 |
| Ascensia Diabetes Care U.S., Inc. | 2 | 2025-05-14 |
| Roche Diabetes Care, Inc. | 2 | 2022-04-29 |
13 more applicants have QRL clearances. See the full list in Caduvo.
Most recent QRL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K262135 | Tianjin Huahong Technology Co., Ltd. | Lancing device | 2026-08-18 | 54 |
| K262211 | Tianjin Huahong Technology Co., Ltd. | Lancet | 2026-07-22 | 22 |
| K260122 | SteriLance Medical (Suzhou), Inc. | Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep) | 2026-07-06 | 172 |
| K253706 | Tianjin Huahong Technology Co., Ltd. | Lancing device (HH-XV-T) | 2025-12-09 | 15 |
| K250813 | Ascensia Diabetes Care U.S., Inc. | MICROLET®NEXT 2 Lancing Device | 2025-05-14 | 58 |
Recalls for QRL devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-07-25.
| Year | Recalls |
|---|---|
| 2025 | 1 |
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- Q4240 — Corecyte, for topical use only, per 0.5 cc
- Q4241 — Polycyte, for topical use only, per 0.5 cc
Frequently asked questions
What is FDA product code QRL?
QRL is the FDA product code for multiple use blood lancet for single patient use only. 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 QRL?
Class II, regulation 21 CFR 878.4850. Typical premarket route: 510(k).
How long does a 510(k) take for product code QRL?
Across 27 cleared submissions the average was 104 days from receipt to decision (median 88).
Which companies have the most QRL clearances?
Tianjin Huahong Technology Co., Ltd. (5); Facet Technologies, LLC (3); SteriLance Medical (Suzhou), Inc. (2); Ascensia Diabetes Care U.S., Inc. (2); Roche Diabetes Care, Inc. (2).
Have QRL devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2025-07-25.
Next steps
- Run an FDA pathway report with predicate devices for product code QRL
- Run a recall and safety report across every QRL manufacturer
- Watch product code QRL 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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