510(k) · Cleared
ClearedDisposable Blood Lancets
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Huaian Hening Medical Instruments Co., Ltd. · QRK Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
Cleared on Jan 25, 2023 as substantially equivalent to K192666 (Promisemed Hangzhou Meditech Co., Ltd., 2019) after an 89-day review. Its family tree reaches back 3 generations to 1982.
- Decided
- Jan 25, 2023
- Review
- 89 days
- Class
- Class II
- Product code
- QRK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K822209 (1982). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK822209 AutolancetBd Becton Dickinson Vacutainer Systems Preanalytic · 1982
- 2 generations backK101145 Surgilance Safety Lancets, Models SLN100, SLN200, SLN240, SLN300…Medipurpose Pte., Ltd. · 2010
- 1 generation backK192666 Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine…Promisemed Hangzhou Meditech Co., Ltd. · 2019
- This deviceK223314 Disposable Blood LancetsHuaian Hening Medical Instruments Co., Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K822209 | Autolancet | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1982 | — |
| −2 | K101145 | Surgilance Safety Lancets, Models SLN100, SLN200, SLN240, SLN300, SLB200, SLB250 | Medipurpose Pte., Ltd. | 2010 | — |
| −1 | K192666 | Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet | Promisemed Hangzhou Meditech Co., Ltd. | 2019 | — |
| 0 (this device) | K223314 | Disposable Blood Lancets | Huaian Hening Medical Instruments Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2012 | 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 QRK? 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 QRK device
- #1 K221507 Disposable Blood Lancetscore 16.5 · 3 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 |
|---|---|---|---|
| * | K192666 | Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety LancetSummary page 4…ancet Common name: Blood Lancet Classification: Class I, Lancet, Blood, 21CFR 878.4800 Product Code: FMK Premarket Notification: K192666 Manufacturer: Promisemed Hangzhou Meditech Co., Ltd. IV Device description The Disposable Blood Lancets consists of… | 2019 |
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 41 years and passes through 4 companies; a new generation was cleared every 9.1 years on median.
- None of the 5 ancestors has a recall.
- 11 other devices also cite its predicate K192666.
How does its category compare?
All QRK devicesQRK Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QRK
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QRK
55in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QRK
No recall names QRK since 2007.
Adverse event reports per year · QRK
9in 2025
MAUDE reports naming product code QRK, 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 | 3 | 100 | 0 | 2 |
| 2023 | 7 | 89 | 0 | 12 |
| 2024 | 3 | 55 | 0 | 10 |
| 2025 | 2 | — | 0 | 9 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Disposable Blood Lancets
The product is used to obtain capillary blood samples from fingertip in a hospital or at home. The lancet is assembled with lancing device, once the lancing device is launched, the needle of lancet can prick the skin.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223314 · printed Nov 5, 2026
Cite this page
510(k) Report. “K223314: Disposable Blood Lancets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K223314
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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