510(k) · Cleared
ClearedAccu-Chek Softclix Blood Lancing System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diabetes Care, Inc. · QRL Multiple Use Blood Lancet For Single Patient Use Only
Cleared on Feb 17, 2022 as substantially equivalent to K810075 (Biodynamics Corp., 1981) after a 57-day review. Its family tree reaches back 1 generation to 1981. 12 later devices descend from it.
- Decided
- Feb 17, 2022
- Review
- 57 days
- Class
- Class II
- Product code
- QRL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K810075 (1981). 12 later devices descend from it, 12 citing it directly.
- Root · 1 generation backK810075 AutoclixBiodynamics Corp. · 1981
- This deviceK214022 Accu-Chek Softclix Blood Lancing SystemRoche Diabetes Care, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK230712 SG Lanset I, SG Lancets, Soft LancetsSewon Medical Co. · 2023
- Descendant · cites it directly · 0 of its ownK230310 STAT Medical Device Lancing SystemStat Medical Devices · 2023
- Descendant · cites it directly · 0 of its ownK222617 EasyTouch Lancing DeviceStat Medical Devices · 2023
- Descendant · cites it directly · 0 of its ownK223815 ONE DROP Lancing DeviceStat Medical Devices · 2023
- Descendant · cites it directly · 0 of its ownK221419 TD-5010 Lancing Device and TD-5084 Sterile LancetsGostar Co., Ltd. · 2023
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K230712SG Lanset I, SG Lancets, Soft LancetsSewon Medical Co. · 2023 · cites it directly0descendants
- K230310STAT Medical Device Lancing SystemStat Medical Devices · 2023 · cites it directly0descendants
- K222617EasyTouch Lancing DeviceStat Medical Devices · 2023 · cites it directly0descendants
- K223815ONE DROP Lancing DeviceStat Medical Devices · 2023 · cites it directly0descendants
- K221419TD-5010 Lancing Device and TD-5084 Sterile LancetsGostar Co., Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K810075 | Autoclix | Biodynamics Corp. | 1981 | — |
| 0 (this device) | K214022 | Accu-Chek Softclix Blood Lancing System | Roche Diabetes Care, Inc. | 2022 | — |
| +1 | K230712 | SG Lanset I, SG Lancets, Soft Lancets | Sewon Medical Co. | 2023 | — |
| +1 | K230310 | STAT Medical Device Lancing System | Stat Medical Devices | 2023 | — |
| +1 | K222617 | EasyTouch Lancing Device | Stat Medical Devices | 2023 | — |
| +1 | K223815 | ONE DROP Lancing Device | Stat Medical Devices | 2023 | — |
| +1 | K221419 | TD-5010 Lancing Device and TD-5084 Sterile Lancets | Gostar Co., Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 7 | 0 |
| 2023 | 5 | 0 |
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 K243306 Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA…score 18.2 · 4 generations · 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 |
|---|---|---|---|
| * | K810075 | AutoclixSummary page 4…s Classification Names: Blood Lancets Regulation Number: 878.4850, Class II Product Code: QRL, QRK Legally Marketed Predicate Devices [21 CFR 807.92(a)(3)] Predicate #: K810075 Predicate Trade Name: Autoclix Lancet Product Code: FMK Device Description Summary [21 CFR 807.92(a)(4)] The Accu-Chek Softclix… | 1981 |
What descends from it? (12)
See all 1212 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230712 | SG Lanset I, SG Lancets, Soft Lancets | 2023 | 0 |
| K230310 | STAT Medical Device Lancing System | 2023 | 0 |
| K222617 | EasyTouch Lancing Device | 2023 | 0 |
| K223815 | ONE DROP Lancing Device | 2023 | 0 |
| K221419 | TD-5010 Lancing Device and TD-5084 Sterile Lancets | 2023 | 0 |
| K222472 | Lancing System, Sterile Lancet for Single Use, Lancing Device | 2022 | 0 |
| K221072 | TRUEdraw Lancing Device, Mini Lancing Device | 2022 | 0 |
| K221175 | Multi-Lancet Device 2, ReliOn Premier Lancing Device | 2022 | 0 |
| K221613 | Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets | 2022 | 0 |
| K222034 | RightLance Blood Lancing System | 2022 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K230712 (Sewon Medical Co., 2023) has gone furthest, with 0 descendants of its own.
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?
The Accu-Chek Softclix Blood 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 sterile, single-use lancets are to be used with the reusable lancing device that is to be cleaned and disinfected between each use, and then the lancets are to be disposed of.
This system is for use only on a single patient in a home setting.
This system is not suitable for use by healthcare professionals with multiple patients in a healthcare setting.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K214022 · printed Nov 6, 2026
Cite this page
510(k) Report. “K214022: Accu-Chek Softclix Blood Lancing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K214022
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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