510(k) · Cleared
ClearedGenteel Lancing Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Genteel, LLC · FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Cleared on May 12, 2016 as substantially equivalent to K113332 (ACON Laboratories, Inc., 2012) after a 143-day review. Its family tree reaches back 3 generations to 2000. 3 later devices descend from it.
- Decided
- May 12, 2016
- Review
- 143 days
- Class
- Class II
- Product code
- FMK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K002134 (2000). 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK002134 One Touch Ultra Blood Glucose Monitoring SystemSelfcare, Inc. · 2000
- 2 generations backK090057 ON-Call Plus Blood Glucose Monitoring SystemAcon Laboratories Co. · 2009
- 1 generation backK113332 ON Call Chosen Lancing DeviceACON Laboratories, Inc. · 2012
- This deviceK153670 Genteel Lancing DeviceGenteel, LLC · 2016
- Descendant · cites it directly · 1 of its ownK221062 RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing…Bionime Corporation · 2022
- Descendant · 2 generations on · 0 of its ownK231797 Medifun Lancing Device, Model No. LD-E1Medifun Corporation · 2023
- Descendant · cites it directly · 0 of its ownK223643 Verifine® Ease Lancing Device, Verifine® Lancing DevicePromisemed Hangzhou Meditech Co., Ltd. · 2023
Most influential descendants
Showing 3 of 3 · See all- K221062RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing DeviceBionime Corporation · 2022 · cites it directly1descendant
- K231797Medifun Lancing Device, Model No. LD-E1Medifun Corporation · 2023 · 2 generations on0descendants
- K223643Verifine® Ease Lancing Device, Verifine® Lancing DevicePromisemed Hangzhou Meditech Co., Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K002134 | One Touch Ultra Blood Glucose Monitoring System | Selfcare, Inc. | 2000 | — |
| −2 | K090057 | ON-Call Plus Blood Glucose Monitoring System | Acon Laboratories Co. | 2009 | — |
| −1 | K113332 | ON Call Chosen Lancing Device | ACON Laboratories, Inc. | 2012 | — |
| 0 (this device) | K153670 | Genteel Lancing Device | Genteel, LLC | 2016 | — |
| +1 | K221062 | RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device | Bionime Corporation | 2022 | — |
| +2 | K231797 | Medifun Lancing Device, Model No. LD-E1 | Medifun Corporation | 2023 | — |
| +1 | K223643 | Verifine® Ease Lancing Device, Verifine® Lancing Device | Promisemed Hangzhou Meditech Co., Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 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? (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 |
|---|---|---|---|
| * | K113332 | ON Call Chosen Lancing DeviceSummary page 4…lancet) Classification Name: Manual surgical instrument for general use (21 CFR 878.4800, Product Code: FMK) 5. Predicate device: 510(K) Number: K113332 Device Name: On Call® Lancing Device Applicant: Acon Laboratories, Inc. 510(K) Numbe… | 2012 |
| * | — | Autolet® Impression Lancing Device Named without a submission number |
What descends from it? (3)
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?
- The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 4.1 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K221062 (Bionime Corporation, 2022) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K113332.
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. 2016, 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 Genteel lancing device is used with disposable sterile lancets to draw capillary blood from the fingertip or alternate sites for blood glucose testing or other testing utilizing small amounts of blood.
The Genteel lancing device is for Single Patient Use Only.
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/K153670 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153670: Genteel Lancing Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153670
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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