510(k) · Cleared
ClearedSafety lancet (XXVIII, XXIX, XXX, XXXI, XXXII, XXXIII, XXXIV.)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tianjin Huahong Technology Co., Ltd. · FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Cleared on May 21, 2024 as substantially equivalent to K220370 (Tianjin Huahong Technology Co., Ltd., 2022) after a 57-day review. Its family tree reaches back 4 generations to 1982. 3 later devices descend from it.
- Decided
- May 21, 2024
- Review
- 57 days
- Class
- Class II
- Product code
- FMK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K822209 (1982). 6 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK822209 AutolancetBd Becton Dickinson Vacutainer Systems Preanalytic · 1982
- 3 generations backK101145 Surgilance Safety Lancets, Models SLN100, SLN200, SLN240, SLN300…Medipurpose Pte., Ltd. · 2010
- 2 generations backK192666 Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine…Promisemed Hangzhou Meditech Co., Ltd. · 2019
- 1 generation backK220370 Safety Lancet (XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVI)Tianjin Huahong Technology Co., Ltd. · 2022
- This deviceK240806 Safety lancet (XXVIII, XXIX, XXX, XXXI, XXXII, XXXIII, XXXIV.)Tianjin Huahong Technology Co., Ltd. · 2024
- Descendant · cites it directly · 1 of its ownK260191 Safety lancet (XXXVII)Tianjin Huahong Technology Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK262526 Safety lancet (XL)Tianjin Huahong Technology Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK251694 safety lancetTianjin Huahong Technology Co., Ltd. · 2025
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K822209 | Autolancet | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1982 | — |
| −3 | K101145 | Surgilance Safety Lancets, Models SLN100, SLN200, SLN240, SLN300, SLB200, SLB250 | Medipurpose Pte., Ltd. | 2010 | — |
| −2 | K192666 | Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet | Promisemed Hangzhou Meditech Co., Ltd. | 2019 | — |
| −1 | K220370 | Safety Lancet (XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVI) | Tianjin Huahong Technology Co., Ltd. | 2022 | — |
| 0 (this device) | K240806 | Safety lancet (XXVIII, XXIX, XXX, XXXI, XXXII, XXXIII, XXXIV.) | Tianjin Huahong Technology Co., Ltd. | 2024 | — |
| +1 | K260191 | Safety lancet (XXXVII) | Tianjin Huahong Technology Co., Ltd. | 2026 | — |
| +2 | K262526 | Safety lancet (XL) | Tianjin Huahong Technology Co., Ltd. | 2026 | — |
| +1 | K251694 | safety lancet | Tianjin Huahong Technology Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
| 2026 | 2 | 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 FMK? 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 FMK device
- #1 K220370 Safety Lancet (XIII, XVII, XXI, XXII, XXIII…score 25.0 · 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 |
|---|---|---|---|
| * | K220370 | Safety Lancet (XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVI)Summary page 4…egulatory Class: Class II Product code: FMK Review Panel General & Plastic Surgery III Predicate Devices 510(k) Number: K220370 Trade name: Safety Lancet Classification: Class II Product Code: FMK Manufacturer Tianjin Huahong… | 2022 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 42 years and passes through 4 companies; a new generation was cleared every 9.1 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K260191 (Tianjin Huahong Technology Co., Ltd., 2026) has gone furthest, with 1 descendant of its own.
- 6 other devices also cite its predicate K220370.
How does its category compare?
All FMK devicesFMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · FMK
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMK
59in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FMK
1in 2009
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FMK
47in 2025
MAUDE reports naming product code FMK, 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 | — | 4 | 1,206 |
| 2008 | 0 | — | 2 | 1,100 |
| 2009 | 0 | — | 1 | 882 |
| 2010 | 2 | — | 0 | 910 |
| 2011 | 0 | — | 0 | 1,493 |
| 2012 | 2 | — | 0 | 1,573 |
| 2013 | 1 | — | 0 | 1,301 |
| 2014 | 0 | — | 0 | 890 |
| 2015 | 0 | — | 0 | 781 |
| 2016 | 1 | — | 0 | 539 |
| 2017 | 1 | — | 0 | 531 |
| 2018 | 0 | — | 0 | 534 |
| 2019 | 2 | — | 0 | 399 |
| 2020 | 0 | — | 0 | 313 |
| 2021 | 1 | — | 0 | 245 |
| 2022 | 25 | 87 | 0 | 254 |
| 2023 | 10 | 95 | 0 | 282 |
| 2024 | 10 | 57 | 0 | 243 |
| 2025 | 4 | 59 | 0 | 47 |
| 2026 | 5 | 68 | 0 | — |
What is it indicated for?
The safety lancet is intended for capillary blood sampling
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/K240806 · printed Nov 4, 2026
Cite this page
510(k) Report. “K240806: Safety lancet (XXVIII, XXIX, XXX, XXXI, XXXII, XXXIII, XXXIV.).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K240806
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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