# K924475: Accudata Glucose Test Station

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Oct 13, 1992 after 40 days
- Product code: CGA (Glucose Oxidase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K983047: Accu-Chek HQ System (1999), 0 descendants of its own

## Recalls of this device
- Jun 22, 2006 · Not classified · Z-1366-06: The meter gives an error message that can "actually" mean either a problem with the strip or a blood glucose too low to measure, but the meter error message only reports that there is a bad strip.
- Jun 22, 2006 · Not classified · Z-1367-06: The meter gives an error message that can "actually" mean either a problem with the strip or a blood glucose too low to measure, but the meter error message only reports that there is a bad strip.
- Jun 22, 2006 · Not classified · Z-1368-06: The meter gives an error message that can "actually" mean either a problem with the strip or a blood glucose too low to measure, but the meter error message only reports that there is a bad strip.
- Apr 18, 2005 · Not classified · Z-0881-05: If foil wrapped packages or other metallic objects are lodged behind the supply drawer, an electrical short may result and high heat generated; this could result in plastic melting and battery leakage
- Apr 18, 2005 · Not classified · Z-0882-05: If foil wrapped packages or other metallic objects are lodged behind the supply drawer, an electrical short may result and high heat generated; this could result in plastic melting and battery leakage
- Apr 18, 2005 · Not classified · Z-0883-05: If foil wrapped packages or other metallic objects are lodged behind the supply drawer, an electrical short may result and high heat generated; this could result in plastic melting and battery leakage

Source page: https://510kreport.com/device/K924475
Methodology: https://510kreport.com/methodology