# K113332: ON Call Chosen Lancing Device

- Pathway: 510(k) (Abbreviated)
- Applicant: ACON Laboratories, Inc.
- Decided: Apr 18, 2012 after 156 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 K002134 (2000). 2 ancestors in all.
16 later devices descend from it; 5 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090057: ON-Call Plus Blood Glucose Monitoring System, Acon Laboratories Co. (2009) Summary page 1.

## Most influential descendants
- 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
- 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
- K153670: Genteel Lancing Device (2016), 3 descendants of its own
- K221970: Lancing device (2022), 2 descendants of its own
- K221062: RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device (2022), 1 descendant of its own

## Indications for use
The On Call® Lancing Device is used with On Call® disposable sterile lancets to draw capillary blood from the fingertip, palm (at the base of the thumb) or forearm, for blood glucose testing or other testing utilizing small amounts of blood. The On Call® Lancing Device is intended to be used by a single patient and should not be shared.

Source page: https://510kreport.com/device/K113332
Methodology: https://510kreport.com/methodology