510(k) · Cleared
ClearedSafety Lancet
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ningbo Medsun Medical Co., Ltd. · FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Cleared on Sep 30, 2022 as substantially equivalent to K192666 (Promisemed Hangzhou Meditech Co., Ltd., 2019) and 1 other predicate after a 77-day review. Its family tree reaches back 3 generations to 1982. 2 later devices descend from it.
- Decided
- Sep 30, 2022
- Review
- 77 days
- Class
- Class II
- Product code
- FMK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K822209 (1982). 5 ancestors in all. 2 later devices descend from it, 2 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 deviceK222090 Safety LancetNingbo Medsun Medical Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK242627 Safety LancetNingbo Medsun Medical Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK242316 Safety LancetNingbo Medsun Medical Co., Ltd. · 2024
Most influential descendants
Showing 2 of 2 · See allView 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) | K222090 | Safety Lancet | Ningbo Medsun Medical Co., Ltd. | 2022 | — |
| +1 | K242627 | Safety Lancet | Ningbo Medsun Medical Co., Ltd. | 2024 | — |
| +1 | K242316 | Safety Lancet | Ningbo Medsun Medical Co., Ltd. | 2024 | — |
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 |
|---|---|---|
| 2024 | 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? (2)
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…l & Plastic Surgery 4.Predicate device 4.1Predicate device A Manufacturer: Promisemed Hangzhou Meditech Co., Ltd. Device name: VeriFine Safety Lancet 510(k) number: K192666 4.2Predicate device B Manufacturer: Medipurpose Pte Ltd. Device name: Surgilance® Safety Lancets 510(k) number: K101145… | 2019 |
| * | K101145 | Surgilance Safety Lancets, Models SLN100, SLN200, SLN240, SLN300, SLB200, SLB250Summary page 4…name: VeriFine Safety Lancet 510(k) number: K192666 4.2Predicate device B Manufacturer: Medipurpose Pte Ltd. Device name: Surgilance® Safety Lancets 510(k) number: K101145 6-1 510(k) Notification document-Safety Lancet… | 2010 |
What descends from it? (2)
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 40 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.
- Of its descendants, K242627 (Ningbo Medsun Medical Co., Ltd., 2024) 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?
Safety Lancet is intended to be used to obtain capillary blood sample to perform medical testing, including blood glucose monitoring and for tests using small amounts of blood.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222090 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222090: 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/K222090
Report an extraction error
Are you the manufacturer?
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