510(k) · Cleared
Clearedgentleheel® Adult Incision Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gri-Alleset, Inc. · FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Cleared on Nov 5, 2024 as substantially equivalent to K220917 (Gri-Alleset, Inc., 2022) and 1 other predicate after a 62-day review. Its family tree reaches back 3 generations to 1988.
- Decided
- Nov 5, 2024
- Review
- 62 days
- Class
- Class II
- Product code
- FMK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K883968 (1988). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK883968 TenderfootInternational Technidyne Corp. · 1988
- 2 generations backK172712 gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn…Gri Medical & Electronic Technology Co., Ltd. · 2017
- 1 generation backK220917 gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn…Gri-Alleset, Inc. · 2022
- This deviceK242664 gentleheel® Adult Incision DeviceGri-Alleset, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K883968 | Tenderfoot | International Technidyne Corp. | 1988 | — |
| −2 | K172712 | gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel… | Gri Medical & Electronic Technology Co., Ltd. | 2017 | — |
| −1 | K220917 | gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel… | Gri-Alleset, Inc. | 2022 | — |
| 0 (this device) | K242664 | gentleheel® Adult Incision Device | Gri-Alleset, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 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? (2)
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 |
|---|---|---|---|
| * | K220917 | gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel ToddlerSummary page 5…ulation Number: 21 CFR 878.4850 Class: II Product Code: FMK Legally Marketed Predicate Device: Predicate: GRI gentleheel®, 510(k) # K220917 and K172712 Device Description: The gentleheel® Adult Incision Device is designed to be an easy to use, safe, one handed inci… | 2022 |
| * | K172712 | gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel ToddlerSummary page 5…er: 21 CFR 878.4850 Class: II Product Code: FMK Legally Marketed Predicate Device: Predicate: GRI gentleheel®, 510(k) # K220917 and K172712 Device Description: The gentleheel® Adult Incision Device is designed to be an easy to use, safe, one handed incision device… | 2017 |
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 36 years and passes through 3 companies; a new generation was cleared every 4.5 years on median.
- None of the 4 ancestors has a recall.
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. 2024, 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 gentleheel® Adult Incision Device is a single-use lancing device intended to obtain microliter capillary blood samples. The gentleheel® Adult Incision Device has a sharps prevention feature to protect the user from a needlestick injury.
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/K242664 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242664: gentleheel® Adult Incision Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242664
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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