# K223243: BD Microtainer® Contact-Activated Lancets; BD Microtainer® Quikheel™ Lancets

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson and Company
- Decided: Dec 16, 2022 after 57 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) BD Microtainer® Contact-Activated Lancets: named in the summary without a submission number
- (no number) BD Microtainer® Quikheel™ Lancets: named in the summary without a submission number

## Indications for use
BD Microtainer® Contact-Activated Lancets The BD Microtainer® Contact-Activated Lancet is a sterile, single‑use, permanently retracting, lancing device used to perform fingerstick punctures in in adults, adolescents, children, and infants (greater than 6 months of age and 10 kg [22 lbs]). The device is intended to be used by a healthcare professional in a clinical setting to obtain capillary blood specimens for testing utilizing small amounts of blood. BD Microtainer® Quikheel™ Lancets The BD Microtainer® Quikheel™ Lancet is a sterile, single-use medical device with a push-button activated, permanently retracting blade. The device is intended to be used by healthcare professionals to perform heel sticks in neonates, pre-term (preemie) and full-term infants (non-walking) to obtain capillary blood specimens for testing utilizing small amounts of blood.

Source page: https://510kreport.com/device/K223243
Methodology: https://510kreport.com/methodology