510(k) · Cleared
ClearedSafety Heel 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 Feb 20, 2026 as substantially equivalent to K210745 (SteriLance Medical (Suzhou), Inc., 2021) after a 94-day review. Its family tree reaches back 4 generations to 2010.
- Decided
- Feb 20, 2026
- Review
- 94 days
- Class
- Class II
- Product code
- FMK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K101417 (2010). No later device cites it as a predicate yet.
- Root · 4 generations backK101417 Babylance Heel Incision Device , Models BLP50, BLP200, BLN50, BLN200Medipurpose Pte., Ltd. · 2010
- 3 generations backK130132 Babylance Heel Incision DeviceMedipurpose Pte., Ltd. · 2013
- 2 generations backK193009 Promisemed Heel Blood LancetPromisemed Hangzhou Meditech Co., Ltd. · 2019
- 1 generation backK210745 Heel Incision Safety LancetSteriLance Medical (Suzhou), Inc. · 2021
- This deviceK253605 Safety Heel LancetNingbo Medsun Medical Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K101417 | Babylance Heel Incision Device , Models BLP50, BLP200, BLN50, BLN200 | Medipurpose Pte., Ltd. | 2010 | — |
| −3 | K130132 | Babylance Heel Incision Device | Medipurpose Pte., Ltd. | 2013 | — |
| −2 | K193009 | Promisemed Heel Blood Lancet | Promisemed Hangzhou Meditech Co., Ltd. | 2019 | — |
| −1 | K210745 | Heel Incision Safety Lancet | SteriLance Medical (Suzhou), Inc. | 2021 | — |
| 0 (this device) | K253605 | Safety Heel Lancet | Ningbo Medsun Medical Co., Ltd. | 2026 | — |
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 |
|---|---|---|---|
| * | K210745 | Heel Incision Safety LancetSummary page 5…anel: General & Plastic Surgery 4.Predicate Device Manufacturer: SteriLance Medical (Suzhou) Inc. Device Name: Heel Incision Safety Lancet 510(k) Number: K210745 5.Device Description Safety Heel Lancet, could be divided into Model D and Model E according to the shape of the trigger l… | 2021 |
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 16 years and passes through 4 companies; a new generation was cleared every 4.5 years on median.
- None of the 4 ancestors has a recall.
- 3 other devices also cite its predicate K210745.
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. 2026, 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 Heel Lancet is a single use device with a sterile blade that is used by medical professionals to obtain a blood sample from the heel of neonates and infants.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253605 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253605: Safety Heel Lancet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253605
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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