510(k) · Cleared
ClearedHeel Incision Safety Lancet
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
SteriLance Medical (Suzhou), Inc. · FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Cleared on Aug 26, 2021 as substantially equivalent to K193009 (Promisemed Hangzhou Meditech Co., Ltd., 2019) after a 167-day review. Its family tree reaches back 3 generations to 2010. 5 later devices descend from it.
- Decided
- Aug 26, 2021
- Review
- 167 days
- Class
- Class II
- Product code
- FMK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K101417 (2010). 5 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK101417 Babylance Heel Incision Device , Models BLP50, BLP200, BLN50, BLN200Medipurpose Pte., Ltd. · 2010
- 2 generations backK130132 Babylance Heel Incision DeviceMedipurpose Pte., Ltd. · 2013
- 1 generation backK193009 Promisemed Heel Blood LancetPromisemed Hangzhou Meditech Co., Ltd. · 2019
- This deviceK210745 Heel Incision Safety LancetSteriLance Medical (Suzhou), Inc. · 2021
- Descendant · cites it directly · 1 of its ownK220372 Heel Stick Safety Lancet (HHZ-II, HHZ-III)Tianjin Huahong Technology Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK253605 Safety Heel LancetNingbo Medsun Medical Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK252490 Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV)Tianjin Huahong Technology Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK244036 Heel Incision Safety Lancet (SteriHeel 2)SteriLance Medical (Suzhou), Inc. · 2025
- Descendant · cites it directly · 0 of its ownK222168 Unistik TinyTouch Sterile Single-Use Heel Incision Safety Lancets -…Owen Mumford, Ltd. · 2022
Most influential descendants
Showing 5 of 5 · See all- K220372Heel Stick Safety Lancet (HHZ-II, HHZ-III)Tianjin Huahong Technology Co., Ltd. · 2022 · cites it directly1descendant
- K253605Safety Heel LancetNingbo Medsun Medical Co., Ltd. · 2026 · cites it directly0descendants
- K252490Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV)Tianjin Huahong Technology Co., Ltd. · 2026 · 2 generations on0descendants
- K244036Heel Incision Safety Lancet (SteriHeel 2)SteriLance Medical (Suzhou), Inc. · 2025 · cites it directly0descendants
- K222168Unistik TinyTouch Sterile Single-Use Heel Incision Safety Lancets - Preemie and…Owen Mumford, Ltd. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K101417 | Babylance Heel Incision Device , Models BLP50, BLP200, BLN50, BLN200 | Medipurpose Pte., Ltd. | 2010 | — |
| −2 | K130132 | Babylance Heel Incision Device | Medipurpose Pte., Ltd. | 2013 | — |
| −1 | K193009 | Promisemed Heel Blood Lancet | Promisemed Hangzhou Meditech Co., Ltd. | 2019 | — |
| 0 (this device) | K210745 | Heel Incision Safety Lancet | SteriLance Medical (Suzhou), Inc. | 2021 | — |
| +1 | K220372 | Heel Stick Safety Lancet (HHZ-II, HHZ-III) | Tianjin Huahong Technology Co., Ltd. | 2022 | — |
| +1 | K253605 | Safety Heel Lancet | Ningbo Medsun Medical Co., Ltd. | 2026 | — |
| +2 | K252490 | Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV) | Tianjin Huahong Technology Co., Ltd. | 2026 | — |
| +1 | K244036 | Heel Incision Safety Lancet (SteriHeel 2) | SteriLance Medical (Suzhou), Inc. | 2025 | — |
| +1 | K222168 | Unistik TinyTouch Sterile Single-Use Heel Incision Safety Lancets - Preemie… | Owen Mumford, Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 2 | 0 |
| 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 |
|---|---|---|---|
| * | K193009 | Promisemed Heel Blood LancetSummary page 4…21 CFR 878.4800 Regulation class I Regulation name Manual Surgical Instrument for General Use 510(k) Number K193009 Product Code FMK Manufacturer Promisemed Hangzhou Meditech Co., Ltd.… | 2019 |
What descends from it? (5)
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 11 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K220372 (Tianjin Huahong Technology Co., Ltd., 2022) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K193009.
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. 2021, 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?
Heel Incision Safety Lancet is intended for the collection of capillary blood from the heel of newborn, preemie, and toddler. The lancet has equipped with safety protection features.
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/K210745 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210745: Heel Incision 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/K210745
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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