510(k) · Cleared
ClearedDisposable Sterile Lancet
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tianjin Rilifine Medical Device Co., Ltd. · QRL Multiple Use Blood Lancet For Single Patient Use Only
Cleared on Nov 21, 2022 as substantially equivalent to K220475 (Tianjin Huahong Technology Co., Ltd., 2022) after a 118-day review. Its family tree reaches back 4 generations to 2000.
- Decided
- Nov 21, 2022
- Review
- 118 days
- Class
- Class II
- Product code
- QRL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K002134 (2000). 9 ancestors in all, the oldest K822209 (1982). No later device cites it as a predicate yet.
- Root · 4 generations backK002134 One Touch Ultra Blood Glucose Monitoring SystemSelfcare, Inc. · 2000
- 3 generations backK090057 ON-Call Plus Blood Glucose Monitoring SystemAcon Laboratories Co. · 2009
- 2 generations backK113332 ON Call Chosen Lancing DeviceACON Laboratories, Inc. · 2012
- 1 generation backK220475 Lancet (I, II, III, V, VI); Lancing device (HH-X-T, HH-XIII-T…Tianjin Huahong Technology Co., Ltd. · 2022
- This deviceK222246 Disposable Sterile LancetTianjin Rilifine Medical Device Co., Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K002134 | One Touch Ultra Blood Glucose Monitoring System | Selfcare, Inc. | 2000 | — |
| −3 | K090057 | ON-Call Plus Blood Glucose Monitoring System | Acon Laboratories Co. | 2009 | — |
| −2 | K113332 | ON Call Chosen Lancing Device | ACON Laboratories, Inc. | 2012 | — |
| −1 | K220475 | Lancet (I, II, III, V, VI); Lancing device (HH-X-T, HH-XIII-T, HH-XV-T… | Tianjin Huahong Technology Co., Ltd. | 2022 | — |
| 0 (this device) | K222246 | Disposable Sterile Lancet | Tianjin Rilifine Medical Device Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1993 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2019 | 1 | 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 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 |
|---|---|---|---|
| * | K220475 | Lancet (I, II, III, V, VI); Lancing device (HH-X-T, HH-XIII-T, HH-XV-T, HH-XVI-T…Summary page 4…4.0 Predicate Device Information Manufacturer: Tianjin Huahong Technology Co., Ltd. Device: Lancet, lancing device 510(k) Number: K220475 Classification II Product Code QRL, QRK 5.0 Intended Use 1 of 6 =… | 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 5 companies; a new generation was cleared every 8.7 years on median.
- None of the 9 ancestors has a recall.
- 3 other devices also cite its predicate K220475.
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?
Disposable Sterile Lancet:
The lancet is intended for capillary blood sampling.
Lancing Device:
The Lancing Device is used with lancets to draw capillary blood from the fingertip, for testing utilizing small amounts of blood. The Lancing Device is single patient use only and should not be shared with anyone else, even a family member.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222246 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222246: Disposable Sterile Lancet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K222246
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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