510(k) · Cleared
ClearedBabylance Heel Incision Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medipurpose Pte., Ltd. · FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Cleared on Feb 11, 2013 as substantially equivalent to K101417 (Medipurpose Pte., Ltd., 2010) after a 24-day review. Its family tree reaches back 1 generation to 2010. 9 later devices descend from it.
- Decided
- Feb 11, 2013
- Review
- 24 days
- Class
- Class II
- Product code
- FMK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K101417 (2010). 9 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK101417 Babylance Heel Incision Device , Models BLP50, BLP200, BLN50, BLN200Medipurpose Pte., Ltd. · 2010
- This deviceK130132 Babylance Heel Incision DeviceMedipurpose Pte., Ltd. · 2013
- Descendant · cites it directly · 7 of its ownK193009 Promisemed Heel Blood LancetPromisemed Hangzhou Meditech Co., Ltd. · 2019
- Descendant · 2 generations on · 5 of its ownK210745 Heel Incision Safety LancetSteriLance Medical (Suzhou), Inc. · 2021
- Descendant · 3 generations on · 1 of its ownK220372 Heel Stick Safety Lancet (HHZ-II, HHZ-III)Tianjin Huahong Technology Co., Ltd. · 2022
- Descendant · 3 generations on · 0 of its ownK253605 Safety Heel LancetNingbo Medsun Medical Co., Ltd. · 2026
- Descendant · 4 generations on · 0 of its ownK252490 Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV)Tianjin Huahong Technology Co., Ltd. · 2026
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K193009Promisemed Heel Blood LancetPromisemed Hangzhou Meditech Co., Ltd. · 2019 · cites it directly7descendants
- K210745Heel Incision Safety LancetSteriLance Medical (Suzhou), Inc. · 2021 · 2 generations on5descendants
- K220372Heel Stick Safety Lancet (HHZ-II, HHZ-III)Tianjin Huahong Technology Co., Ltd. · 2022 · 3 generations on1descendant
- K253605Safety Heel LancetNingbo Medsun Medical Co., Ltd. · 2026 · 3 generations on0descendants
- K252490Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV)Tianjin Huahong Technology Co., Ltd. · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K101417 | Babylance Heel Incision Device , Models BLP50, BLP200, BLN50, BLN200 | Medipurpose Pte., Ltd. | 2010 | — |
| 0 (this device) | K130132 | Babylance Heel Incision Device | Medipurpose Pte., Ltd. | 2013 | — |
| +1 | K193009 | Promisemed Heel Blood Lancet | Promisemed Hangzhou Meditech Co., Ltd. | 2019 | — |
| +2 | K210745 | Heel Incision Safety Lancet | SteriLance Medical (Suzhou), Inc. | 2021 | — |
| +3 | K220372 | Heel Stick Safety Lancet (HHZ-II, HHZ-III) | Tianjin Huahong Technology Co., Ltd. | 2022 | — |
| +3 | K253605 | Safety Heel Lancet | Ningbo Medsun Medical Co., Ltd. | 2026 | — |
| +4 | K252490 | Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV) | Tianjin Huahong Technology Co., Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 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 |
|---|---|---|---|
| * | K101417 | Babylance Heel Incision Device , Models BLP50, BLP200, BLN50, BLN200Summary page 1…800) Class: 1 and Sharps Prevention Feature Product Code: FMK Legally Marketed babyLance Tm Heel Incision Device, 51 0(k) # K1 01417 Predicate Devices: Device Description: The MediPurpose babyLanceo Heel Incision Device is designed to be a one handed… | 2010 |
What descends from it? (9)
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?
- Its one ancestor has no recall.
- Of its descendants, K193009 (Promisemed Hangzhou Meditech Co., Ltd., 2019) has gone furthest, with 7 descendants of its own.
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. 2013, 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 babyLance® is an incision device to obtain a blood sample from the heel of newborn and preemie infants. The babyLance® has a sharps prevention feature to protect the user from a sharps injury.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130132 · printed Nov 5, 2026
Cite this page
510(k) Report. “K130132: Babylance Heel Incision Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K130132
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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