510(k) · Cleared
ClearedLancing device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tianjin Huahong Technology Co., Ltd. · QRL Multiple Use Blood Lancet For Single Patient Use Only
Cleared on Aug 18, 2026 as substantially equivalent to K243306 (Tianjin Huahong Technology Co., Ltd., 2024) after a 54-day review. Its family tree reaches back 5 generations to 2000.
- Decided
- Aug 18, 2026
- Review
- 54 days
- Class
- Class II
- Product code
- QRL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K002134 (2000). 10 ancestors in all, the oldest K822209 (1982). No later device cites it as a predicate yet.
- Root · 5 generations backK002134 One Touch Ultra Blood Glucose Monitoring SystemSelfcare, Inc. · 2000
- 4 generations backK090057 ON-Call Plus Blood Glucose Monitoring SystemAcon Laboratories Co. · 2009
- 3 generations backK113332 ON Call Chosen Lancing DeviceACON Laboratories, Inc. · 2012
- 2 generations backK220475 Lancet (I, II, III, V, VI); Lancing device (HH-X-T, HH-XIII-T…Tianjin Huahong Technology Co., Ltd. · 2022
- 1 generation backK243306 Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII…Tianjin Huahong Technology Co., Ltd. · 2024
- This deviceK262135 Lancing deviceTianjin Huahong Technology Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K002134 | One Touch Ultra Blood Glucose Monitoring System | Selfcare, Inc. | 2000 | — |
| −4 | K090057 | ON-Call Plus Blood Glucose Monitoring System | Acon Laboratories Co. | 2009 | — |
| −3 | K113332 | ON Call Chosen Lancing Device | ACON Laboratories, Inc. | 2012 | — |
| −2 | K220475 | Lancet (I, II, III, V, VI); Lancing device (HH-X-T, HH-XIII-T, HH-XV-T… | Tianjin Huahong Technology Co., Ltd. | 2022 | — |
| −1 | K243306 | Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX)… | Tianjin Huahong Technology Co., Ltd. | 2024 | — |
| 0 (this device) | K262135 | Lancing device | Tianjin Huahong Technology Co., Ltd. | 2026 | — |
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 |
|---|---|---|---|
| * | K243306 | Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX); Lancing…Summary page 5…850 Regulatory Class: Class II Product code: QRL Review Panel General & Plastic Surgery III Predicate Devices 510(k) Number: K243306 Trade name: Lancet, Lancing device Classification: Class II Product Code: QRL, QRK Manufacturer: Tianjin Huah… | 2024 |
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 26 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
- None of the 10 ancestors has a recall.
- 2 other devices also cite its predicate K243306.
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. 2026, 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?
Model: HH-XXXI-T Without AST cap 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 intended to be used by a single patient and should not be shared. With AST cap The Lancing Device is used with lancets to draw capillary blood from the fingertip, palm (at the base of the thumb) or forearm, for testing utilizing small amounts of blood. The Lancing Device…
Read the full statement (133 words)
Model: HH-XXXI-T
Without AST cap
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 intended to be used by a single patient and should not be shared.
With AST cap
The Lancing Device is used with lancets to draw capillary blood from the fingertip, palm (at the base of the thumb) or forearm, for testing utilizing small amounts of blood. The Lancing Device is intended to be used by a single patient and should not be shared.
Model: HH-XXXII-T
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 intended to be used by a single patient and should not be shared.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K262135 · printed Nov 6, 2026
Cite this page
510(k) Report. “K262135: Lancing device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K262135
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026