# K004010: Accu-Chek Compact System, Accu-Chek Compact Test Strips, Accu-Chek Compact Compact Controls

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Apr 26, 2001 after 121 days
- Product code: LFR (Glucose Dehydrogenase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 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
- K022171: Accu-Chek Compact System (2002), 3 descendants of its own
- K081403: Glucose Meter-Check Control Solution for Roche Accu-Chek (2008), 2 descendants of its own
- K123851: Glucose Meter-Check Solution for Roche Accu-Chek (2013), 1 descendant of its own
- K152493: POGO Automatic Blood Glucose Monitoring System (2016), 0 descendants of its own

Source page: https://510kreport.com/device/K004010
Methodology: https://510kreport.com/methodology