# K192666: Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet

- Pathway: 510(k) (Traditional)
- Applicant: Promisemed Hangzhou Meditech Co., Ltd.
- Decided: Dec 2, 2019 after 68 days
- Product code: FMK (Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature)
- Device class: 2
- Regulation: 21 CFR 878.4850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K822209 (1982). 4 ancestors in all.
45 later devices descend from it; 12 cite it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113513: Plancet, Micropoint Technologies Pte, Ltd. (2012) Summary page 5.
- K101145: Surgilance Safety Lancets, Models SLN100, SLN200, SLN240, SLN300, SLB200, SLB250, Medipurpose Pte., Ltd. (2010) Summary page 5.

## Most influential descendants
- K220370: Safety Lancet (XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVI) (2022), 14 descendants of its own
- K220475: Lancet (I, II, III, V, VI); Lancing device (HH-X-T, HH-XIII-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T) (2022), 7 descendants of its own
- K221507: Disposable Blood Lancet (2022), 5 descendants of its own
- K221368: Promisemed Blood Lancet,  VeriFine Safety Lancet, VeriFine Mini-Safety Lancet (2022), 4 descendants of its own
- K243306: Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX); Lancing device (HH-X-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T, HH-XXV-T, HH-XXVI-T, HH-XXVIII-T, HH-XXIX-T, HH-XXX-T, HH-XIII-T, HH-XXVII-T) (2024), 3 descendants of its own

## Indications for use
It is intended for capillary blood sampling.

Source page: https://510kreport.com/device/K192666
Methodology: https://510kreport.com/methodology