510(k) · Cleared
ClearedbabyLance Safety Heelstick (BLM, BLN, BLP)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Clinical Innovations, LLC · FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Cleared on Feb 24, 2023 as substantially equivalent to K130132 (Medipurpose Pte., Ltd., 2013) after a 58-day review. Its family tree reaches back 2 generations to 2010.
- Decided
- Feb 24, 2023
- Review
- 58 days
- Class
- Class II
- Product code
- FMK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K101417 (2010). No later device cites it as a predicate yet.
- 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 deviceK223900 babyLance Safety Heelstick (BLM, BLN, BLP)Clinical Innovations, LLC · 2023
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) | K223900 | babyLance Safety Heelstick (BLM, BLN, BLP) | Clinical Innovations, LLC | 2023 | — |
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…ion Feature (21 CFR 878.4850, Product Code FMK) Predicate BabyLance Heel Incision Device, 510K number K130132 Device Description The babyLance™ safety heelstick is a sterile, single-use device designed to be a one-handed, automated incisi… | 2013 |
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 13 years and passes through 2 companies; a new generation was cleared every 10.0 years on median.
- None of the 2 ancestors has a recall.
- 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. 2023, 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 safety heelstick is a single-use incision device used to obtain a blood sample from the heel of a neonate or infant. babyLance has a sharps prevention feature to protect the user from a needlestick injury.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223900 · printed Nov 5, 2026
Cite this page
510(k) Report. “K223900: babyLance Safety Heelstick (BLM, BLN, BLP).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K223900
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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