510(k) · Cleared
ClearedPromisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Promisemed Hangzhou Meditech Co., Ltd. · FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Cleared on Jun 9, 2022 as substantially equivalent to K192666 (Promisemed Hangzhou Meditech Co., Ltd., 2019) after a 28-day review. Its family tree reaches back 3 generations to 1982. 4 later devices descend from it.
- Decided
- Jun 9, 2022
- Review
- 28 days
- Class
- Class II
- Product code
- FMK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K822209 (1982). 5 ancestors in all. 4 later devices descend from it, 4 citing it directly.
- 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 deviceK221368 Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine…Promisemed Hangzhou Meditech Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK261045 Verifine Safety LancetsPromisemed Hangzhou Meditech Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK243533 Sterilized Eol Auto Lancet; Sterilized Eol Lancet PlusHlb Co., Ltd. Healthcare · 2025
- Descendant · cites it directly · 0 of its ownK222408 Disposable Safety LancetBeijing Ruicheng Medical Supplies Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK221783 SafetiCET Safety LancetNsp Tech Pte, Ltd. · 2022
Most influential descendants
Showing 4 of 4 · See all- K261045Verifine Safety LancetsPromisemed Hangzhou Meditech Co., Ltd. · 2026 · cites it directly0descendants
- K243533Sterilized Eol Auto Lancet; Sterilized Eol Lancet PlusHlb Co., Ltd. Healthcare · 2025 · cites it directly0descendants
- K222408Disposable Safety LancetBeijing Ruicheng Medical Supplies Co., Ltd. · 2022 · cites it directly0descendants
- K221783SafetiCET Safety LancetNsp Tech Pte, Ltd. · 2022 · cites it directly0descendants
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) | K221368 | Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet | Promisemed Hangzhou Meditech Co., Ltd. | 2022 | — |
| +1 | K261045 | Verifine Safety Lancets | Promisemed Hangzhou Meditech Co., Ltd. | 2026 | — |
| +1 | K243533 | Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus | Hlb Co., Ltd. Healthcare | 2025 | — |
| +1 | K222408 | Disposable Safety Lancet | Beijing Ruicheng Medical Supplies Co., Ltd. | 2022 | — |
| +1 | K221783 | SafetiCET Safety Lancet | Nsp Tech Pte, Ltd. | 2022 | — |
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 |
|---|---|---|
| 2022 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 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 |
|---|---|---|---|
| * | K192666 | Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety LancetSummary page 4…jury Prevention Feature Regulation Number: 21 CFR 878.4850 Device Class: Class II Product Code: FMK, QRK 4 Identification of Predicate Device(s) K192666: Promisemed Blood Lancet 7-1 Promisemed Blood Lancet & Safety Lancet… | 2019 |
What descends from it? (4)
4 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 40 years and passes through 3 companies; a new generation was cleared every 9.1 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K261045 (Promisemed Hangzhou Meditech Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 11 other devices also cite its predicate K192666.
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. 2022, 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?
It 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/K221368 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221368: Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221368
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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