# FMK: Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

- Device class: 2; regulation: 21 CFR 878.4850; FDA's rule: 510(k) required
- FDA decisions: 111
- 510(k) review time 2021–2025: median 86 days (middle half 57–115)
- Recalls: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2013: 1
- 2016: 1
- 2017: 1
- 2019: 2
- 2021: 1
- 2022: 25
- 2023: 10
- 2024: 10
- 2025: 4
- 2026: 5

## Most-cited predicates
- K192666: Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet (2019), cited by 12
- K101145: Surgilance Safety Lancets, Models SLN100, SLN200, SLN240, SLN300, SLB200, SLB250 (2010), cited by 11
- K220370: Safety Lancet (XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVI) (2022), cited by 7
- K113332: ON Call Chosen Lancing Device (2012), cited by 5
- K210745: Heel Incision Safety Lancet (2021), cited by 4
- K221368: Promisemed Blood Lancet,  VeriFine Safety Lancet, VeriFine Mini-Safety Lancet (2022), cited by 4
- K883968: Tenderfoot (1988), cited by 3
- K911997: Tenderfoot (R), Modification (1991), cited by 3
- K822209: Autolancet (1982), cited by 2
- K172712: gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler (2017), cited by 2

Source page: https://510kreport.com/product-code/FMK
Data by year (CSV): https://510kreport.com/product-code/FMK.csv