510(k) · Cleared
Clearedgentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gri Medical & Electronic Technology Co., Ltd. · FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Cleared on Nov 6, 2017 as substantially equivalent to K883968 (International Technidyne Corp., 1988) and 1 other predicate after a 59-day review. Its family tree reaches back 1 generation to 1988. 2 later devices descend from it.
- Decided
- Nov 6, 2017
- Review
- 59 days
- Class
- Class II
- Product code
- FMK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K883968 (1988). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK883968 TenderfootInternational Technidyne Corp. · 1988
- This deviceK172712 gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn…Gri Medical & Electronic Technology Co., Ltd. · 2017
- Descendant · cites it directly · 1 of its ownK220917 gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn…Gri-Alleset, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK242664 gentleheel® Adult Incision DeviceGri-Alleset, Inc. · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K883968 | Tenderfoot | International Technidyne Corp. | 1988 | — |
| 0 (this device) | 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 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K883968 | TenderfootSummary page 4…neral use Class: 1 and Sharps Prevention Feature Product Code: FMK Legally Marketed Predicate Device: ITC Tenderfoot®, 510(k) # K883968 & K911997 Device Description: The gentleheel is designed to be an easy to use, safe, one handed heel incision device for acqu… | 1988 |
| * | K911997 | Tenderfoot (R), ModificationSummary page 4…Class: 1 and Sharps Prevention Feature Product Code: FMK Legally Marketed Predicate Device: ITC Tenderfoot®, 510(k) # K883968 & K911997 Device Description: The gentleheel is designed to be an easy to use, safe, one handed heel incision device for acquiring bloo… | 1991 |
What descends from it? (2)
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?
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. 2017, 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® devices are heel incision devices for blood sampling in newborns, premature and low birth weight infants, and toddlers. The gentleheel 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/K172712 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172712: gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172712
Report an extraction error
Are you the manufacturer?
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