510(k) · Cleared
ClearedOneTouch Delica Safety, HemoCue Safety Lancet, Assure Lance and Assure Lance Plus, Capiject Safety Lancet, Heel Lancet Newborn, Heel Lancet Preemie
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Asahi Polyslider Co., Ltd. · FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Cleared on Nov 2, 2022 as substantially equivalent to K101145 (Medipurpose Pte., Ltd., 2010) after a 110-day review. Its family tree reaches back 2 generations to 1982.
- Decided
- Nov 2, 2022
- Review
- 110 days
- Class
- Class II
- Product code
- FMK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K822209 (1982). No later device cites it as a predicate yet.
- Root · 2 generations backK822209 AutolancetBd Becton Dickinson Vacutainer Systems Preanalytic · 1982
- 1 generation backK101145 Surgilance Safety Lancets, Models SLN100, SLN200, SLN240, SLN300…Medipurpose Pte., Ltd. · 2010
- This deviceK222084 OneTouch Delica Safety, HemoCue Safety Lancet, Assure Lance and…Asahi Polyslider Co., Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K822209 | Autolancet | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1982 | — |
| −1 | K101145 | Surgilance Safety Lancets, Models SLN100, SLN200, SLN240, SLN300, SLB200, SLB250 | Medipurpose Pte., Ltd. | 2010 | — |
| 0 (this device) | K222084 | OneTouch Delica Safety, HemoCue Safety Lancet, Assure Lance and Assure Lance… | Asahi Polyslider Co., Ltd. | 2022 | — |
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? (1)
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 |
|---|---|---|---|
| * | K101145 | Surgilance Safety Lancets, Models SLN100, SLN200, SLN240, SLN300, SLB200, SLB250Summary page 5…ic Surgery 5. Legally Marketed Predicate and Reverence Devices Predicate Device Device name: SurgiLance® Safety Lancet 510(k) number: K101145 Manufacturer: MediPurpose Page 1 of 5 Refere… | 2010 |
| † | K221546 | OneTouch Delica Plus Lancing System | 2022 |
| † | K192666 | Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet | 2019 |
| † | K220364 | Accu-Chek Safe-T-Pro Uno Lancing Device | 2022 |
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 40 years and passes through 3 companies; a new generation was cleared every 28.2 years on median.
- None of the 2 ancestors has a recall.
- 10 other devices also cite its predicate K101145.
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. 2022, 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?
OneTouch® Delica® Safety is a single use blood lancet with sharps prevention feature to protect the user from a needlestick injury and that is intended for capillary blood sampling from a fingertip. HemoCue® Safety Lancet is single use and intended for capillary blood sampling from a fingertip. Sharps prevention feature protects the user from needlestick injury. Assure® Lance Safety Lancets are single use and intended for capillary blood sampling from a…
Read the full statement (183 words)
OneTouch® Delica® Safety is a single use blood lancet with sharps prevention feature to protect the user from a needlestick injury and that is intended for capillary blood sampling from a fingertip.
HemoCue® Safety Lancet is single use and intended for capillary blood sampling from a fingertip. Sharps prevention feature protects the user from needlestick injury.
Assure® Lance Safety Lancets are single use and intended for capillary blood sampling from a fingertip. Sharps prevention feature protects the user from needlestick injury.
Assure® Lance Plus Safety Lancets are single use and intended for capillary blood sampling from a fingertip. Sharps prevention feature protects the user from needlestick injury.
Capiject® Safety Lancet is single use and intended for capillary blood sampling from a fingertip. Sharps prevention feature protects the user from needlestick injury.
Heel Lancet Newborn is single use and intended for capillary blood sampling from a heel for newborn. Sharps prevention feature protects the user from needlestick injury.
Heel Lancet Preemie is single use and intended for capillary blood sampling from a heel for preemie. Sharps prevention feature protects the user from 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/K222084 · printed Nov 5, 2026
Cite this page
510(k) Report. “K222084: OneTouch Delica Safety, HemoCue Safety Lancet, Assure Lance and Assure Lance Plus, Capiject Safety Lancet, Heel Lancet Newborn, Heel Lancet Preemie.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K222084
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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