# K083223: Relion Ultima Blood Glucose Monitoring System, Models 70055-50, Strips (20 Count): 70973-01

- Pathway: 510(k) (Special)
- Applicant: Abbott Diabetes Care, Inc.
- Decided: Apr 16, 2009 after 164 days
- Product code: LFR (Glucose Dehydrogenase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K140371: Freestyle Precision Neo Blood Glucose: Monitoring System, Test Strips (50CT), Test Strips (100CT) (2014), 2 descendants of its own
- K171941: FreeStyle Precision Neo Blood Glucose Test Strips (2017), 0 descendants of its own
- K142928: FreeStyle Precision Neo Blood Glucose Monitoring System (2015), 0 descendants of its own

## Recalls of this device
- Dec 22, 2010 · Not classified · Z-1000-2011: Certain lots of Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium, OptiumEZ and ReliOn Ultima Blood Glucose Test Strips may generate erroneously low blood glucose results.

Source page: https://510kreport.com/device/K083223
Methodology: https://510kreport.com/methodology