510(k) · Cleared
ClearedTenderfoot (R), Modification
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
International Technidyne Corp. · FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Cleared on Jul 17, 1991 after an 86-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it.
- Decided
- Jul 17, 1991
- Review
- 86 days
- Class
- Class II
- Product code
- FMK
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK911997 Tenderfoot (R), ModificationInternational Technidyne Corp. · 1991
- Descendant · cites it directly · 2 of its ownK172712 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 · 2 generations on · 0 of its ownK242664 gentleheel® Adult Incision DeviceGri-Alleset, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK223352 TenderfootAccriva Diagnostics, Inc. · 2023
Most influential descendants
Showing 4 of 4 · See all- K172712gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel ToddlerGri Medical & Electronic Technology Co., Ltd. · 2017 · cites it directly2descendants
- K220917gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel ToddlerGri-Alleset, Inc. · 2022 · cites it directly1descendant
- K242664gentleheel® Adult Incision DeviceGri-Alleset, Inc. · 2024 · 2 generations on0descendants
- K223352TenderfootAccriva Diagnostics, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K911997 | Tenderfoot (R), Modification | International Technidyne Corp. | 1991 | — |
| +1 | 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 | — |
| +2 | K242664 | gentleheel® Adult Incision Device | Gri-Alleset, Inc. | 2024 | — |
| +1 | K223352 | Tenderfoot | Accriva Diagnostics, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (4)
3 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?
- Of its descendants, K172712 (Gri Medical & Electronic Technology Co., Ltd., 2017) has gone furthest, with 2 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.
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 | — |
https://510kreport.com/device/K911997 · printed Nov 6, 2026
Cite this page
510(k) Report. “K911997: Tenderfoot (R), Modification.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K911997
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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