# K113513: Plancet

- Pathway: 510(k) (Traditional)
- Applicant: Micropoint Technologies Pte, Ltd.
- Decided: Jul 13, 2012 after 228 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: 1 generation back to K931827 (1993). 1 ancestor in all.
46 later devices descend from it; 1 cites it directly.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K931827: Cleanlet, Cleanlet XL & Kids, Gainor Medical Europe, Ltd. (1993) Summary page 1.

## Most influential descendants
- K192666: Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet (2019), 45 descendants of its own
- 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

## Indications for use
The PLANCET blood lancet is a puncture device to obtain micro-litre capillary whole blood samples from finger tips or palm or alternate body sites. The PLANCET blood lancet is normally loaded in a spring-operated lancing device for rapid puncture of skin.

Source page: https://510kreport.com/device/K113513
Methodology: https://510kreport.com/methodology