510(k) · Cleared
ClearedAutoclix
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biodynamics Corp. · FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Cleared on Feb 4, 1981 after a 22-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 13 later devices descend from it.
- Decided
- Feb 4, 1981
- Review
- 22 days
- Class
- Class II
- Product code
- FMK
- Recalls
- None
- Predicates
- 0
13 later devices descend from it, 1 citing it directly.
- This deviceK810075 AutoclixBiodynamics Corp. · 1981
- Descendant · cites it directly · 12 of its ownK214022 Accu-Chek Softclix Blood Lancing SystemRoche Diabetes Care, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK230712 SG Lanset I, SG Lancets, Soft LancetsSewon Medical Co. · 2023
- Descendant · 2 generations on · 0 of its ownK230310 STAT Medical Device Lancing SystemStat Medical Devices · 2023
- Descendant · 2 generations on · 0 of its ownK222617 EasyTouch Lancing DeviceStat Medical Devices · 2023
- Descendant · 2 generations on · 0 of its ownK223815 ONE DROP Lancing DeviceStat Medical Devices · 2023
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K214022Accu-Chek Softclix Blood Lancing SystemRoche Diabetes Care, Inc. · 2022 · cites it directly12descendants
- K230712SG Lanset I, SG Lancets, Soft LancetsSewon Medical Co. · 2023 · 2 generations on0descendants
- K230310STAT Medical Device Lancing SystemStat Medical Devices · 2023 · 2 generations on0descendants
- K222617EasyTouch Lancing DeviceStat Medical Devices · 2023 · 2 generations on0descendants
- K223815ONE DROP Lancing DeviceStat Medical Devices · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K810075 | Autoclix | Biodynamics Corp. | 1981 | — |
| +1 | K214022 | Accu-Chek Softclix Blood Lancing System | Roche Diabetes Care, Inc. | 2022 | — |
| +2 | K230712 | SG Lanset I, SG Lancets, Soft Lancets | Sewon Medical Co. | 2023 | — |
| +2 | K230310 | STAT Medical Device Lancing System | Stat Medical Devices | 2023 | — |
| +2 | K222617 | EasyTouch Lancing Device | Stat Medical Devices | 2023 | — |
| +2 | K223815 | ONE DROP Lancing Device | Stat Medical Devices | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 8 | 0 |
| 2023 | 5 | 0 |
Sources: FDA 510(k) database (decision fields), 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (13)
See all 131 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K214022 | Accu-Chek Softclix Blood Lancing System | 2022 | 12 |
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, K214022 (Roche Diabetes Care, Inc., 2022) has gone furthest, with 12 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/K810075 · printed Nov 4, 2026
Cite this page
510(k) Report. “K810075: Autoclix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K810075
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026