510(k) · Cleared
ClearedPromisemed Heel Blood 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 Dec 3, 2019 as substantially equivalent to K130132 (Medipurpose Pte., Ltd., 2013) after a 36-day review. Its family tree reaches back 2 generations to 2010. 7 later devices descend from it.
- Decided
- Dec 3, 2019
- Review
- 36 days
- Class
- Class II
- Product code
- FMK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K101417 (2010). 7 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK101417 Babylance Heel Incision Device , Models BLP50, BLP200, BLN50, BLN200Medipurpose Pte., Ltd. · 2010
- 1 generation backK130132 Babylance Heel Incision DeviceMedipurpose Pte., Ltd. · 2013
- This deviceK193009 Promisemed Heel Blood LancetPromisemed Hangzhou Meditech Co., Ltd. · 2019
- Descendant · cites it directly · 5 of its ownK210745 Heel Incision Safety LancetSteriLance Medical (Suzhou), Inc. · 2021
- Descendant · 2 generations on · 1 of its ownK220372 Heel Stick Safety Lancet (HHZ-II, HHZ-III)Tianjin Huahong Technology Co., Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK253605 Safety Heel LancetNingbo Medsun Medical Co., Ltd. · 2026
- Descendant · 3 generations on · 0 of its ownK252490 Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV)Tianjin Huahong Technology Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK244036 Heel Incision Safety Lancet (SteriHeel 2)SteriLance Medical (Suzhou), Inc. · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K210745Heel Incision Safety LancetSteriLance Medical (Suzhou), Inc. · 2021 · cites it directly5descendants
- K220372Heel Stick Safety Lancet (HHZ-II, HHZ-III)Tianjin Huahong Technology Co., Ltd. · 2022 · 2 generations on1descendant
- K253605Safety Heel LancetNingbo Medsun Medical Co., Ltd. · 2026 · 2 generations on0descendants
- K252490Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV)Tianjin Huahong Technology Co., Ltd. · 2026 · 3 generations on0descendants
- K244036Heel Incision Safety Lancet (SteriHeel 2)SteriLance Medical (Suzhou), Inc. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K101417 | Babylance Heel Incision Device , Models BLP50, BLP200, BLN50, BLN200 | Medipurpose Pte., Ltd. | 2010 | — |
| −1 | K130132 | Babylance Heel Incision Device | Medipurpose Pte., Ltd. | 2013 | — |
| 0 (this device) | K193009 | Promisemed Heel Blood Lancet | Promisemed Hangzhou Meditech Co., Ltd. | 2019 | — |
| +1 | K210745 | Heel Incision Safety Lancet | SteriLance Medical (Suzhou), Inc. | 2021 | — |
| +2 | K220372 | Heel Stick Safety Lancet (HHZ-II, HHZ-III) | Tianjin Huahong Technology Co., Ltd. | 2022 | — |
| +2 | K253605 | Safety Heel Lancet | Ningbo Medsun Medical Co., Ltd. | 2026 | — |
| +3 | K252490 | Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV) | Tianjin Huahong Technology Co., Ltd. | 2026 | — |
| +2 | K244036 | Heel Incision Safety Lancet (SteriHeel 2) | SteriLance Medical (Suzhou), Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 3 | 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 |
|---|---|---|---|
| * | K130132 | Babylance Heel Incision DeviceSummary page 4…Infant Heel Lancet Classification name: Lancet, Blood (21 CFR 878.4800, Product code FMK ) Device Class: Class I 4 Identification of Predicate Device(s) K130132 BabyLance Heel Incision Device 1 Promisemed Heel Blood Lancet… | 2013 |
What descends from it? (7)
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 9 years and passes through 2 companies; a new generation was cleared every 6.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K210745 (SteriLance Medical (Suzhou), Inc., 2021) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K130132.
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. 2019, 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 collection of capillary blood from the heel of newborn and premature babies. The lancet has equipped with safety protection features.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193009 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193009: Promisemed Heel Blood Lancet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193009
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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