510(k) · Cleared
Recalled · Class III · 2025Lancing System, Sterile Lancet for Single Use, Lancing Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shandong Lianfa Medical Plastic Products Co., Ltd. · QRL Multiple Use Blood Lancet For Single Patient Use Only
Cleared on Nov 30, 2022 as substantially equivalent to K214022 (Roche Diabetes Care, Inc., 2022) after a 106-day review. Its family tree reaches back 2 generations to 1981. It has been recalled once.
- Decided
- Nov 30, 2022
- Review
- 106 days
- Class
- Class II
- Product code
- QRL
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K810075 (1981). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K810075 | Autoclix | Biodynamics Corp. | 1981 | — |
| −1 | K214022 | Accu-Chek Softclix Blood Lancing System | Roche Diabetes Care, Inc. | 2022 | — |
| 0 (this device) | K222472 | Lancing System, Sterile Lancet for Single Use, Lancing Device | Shandong Lianfa Medical Plastic Products Co., Ltd. | 2022 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QRL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QRL device
- #1 K214022 Accu-Chek Softclix Blood Lancing Systemscore 38.9 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K214022 | Accu-Chek Softclix Blood Lancing SystemSummary page 5…uct Code: QRK Page 1 of 6 K222472 5 Predicate Device Information: K214022, “Accu-Chek Softclix Blood Lancing System”, manufactured by “Roche Diabetes Care, Inc.” 6 Device Description: “Lancing Sys… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 25, 2025 | Class III | Z-0226-2026 | Error in labeling | Due to incorrect/lack of Unique Device Identifier (UDI) codes. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 41 years and passes through 3 companies; a new generation was cleared every 41.0 years on median.
- None of the 2 ancestors has a recall.
- 11 other devices also cite its predicate K214022.
How does its category compare?
All QRL devicesQRL Multiple Use Blood Lancet For Single Patient Use Only: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · QRL
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QRL
155in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QRL
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QRL
133in 2025
MAUDE reports naming product code QRL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 17 | 91 | 0 | 1 |
| 2023 | 3 | 155 | 0 | 3 |
| 2024 | 2 | — | 0 | 7 |
| 2025 | 2 | — | 1 | 133 |
| 2026 | 3 | 54 | 0 | — |
What is it indicated for?
“Lancing System” consists of “Sterile Lancet for Single Use” and “Lancing Device” The Lancing System is intended for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the palm, the upper arm, and the forearm. The reusable lancing device is to be used with sterile, single-use lancets, and is to be cleaned and disinfected between each use, and then the lancets are to be disposed…
Read the full statement (148 words)
“Lancing System” consists of “Sterile Lancet for Single Use” and “Lancing Device”
The Lancing System is intended for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the palm, the upper arm, and the forearm.
The reusable lancing device is to be used with sterile, single-use lancets, and is to be cleaned and disinfected between each use, and then the lancets are to be disposed of.
The lancing device is for use only on a single patient in a home setting. This lancing device is not suitable for use by healthcare professionals with multiple patients in a healthcare setting.
“Sterile Lancet for Single Use” is a single use device indicated for capillary blood sampling. It can be used in conjunction with “Lancing Device” in home settings, or be used standalone in both home and hospital settings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222472 · printed Nov 4, 2026
Cite this page
510(k) Report. “K222472: Lancing System, Sterile Lancet for Single Use, Lancing Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K222472
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026