# K220633: MICROLET NEXT lancing device, MICROLET Lancet

- Pathway: 510(k) (Traditional)
- Applicant: Ascensia Diabetes Care U.S., Inc.
- Decided: Jun 3, 2022 after 91 days
- Product code: QRL (Multiple Use Blood Lancet For Single Patient Use Only)
- 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) MICROLET® Lancet/MICROLET® NEXT lancing device (510(k)-exempt): named in the summary without a submission number

## Indications for use
The MICROLET@NEXT lancing device is intended for collecting capillary blood from the fingertip or palm for blood glucose testing or other testing utilizing small amounts of blood. The MICROLET NEXT lancing device is for single-patient use. The MICROLET NEXT lancing device is used with disposable, sterile MICROLET@ lancets. The MICROLET NEXT lancing device with the MICROLET lancet are intended for collecting fingertip capillary blood from persons age two years and older. The alternative site testing endcap is intended for collecting capillary blood from the palm in adults only.

Source page: https://510kreport.com/device/K220633
Methodology: https://510kreport.com/methodology