# K982079: Accu-Check Voicemate

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Aug 28, 1998 after 74 days
- Product code: LFR (Glucose Dehydrogenase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: 3 (0 Class I)
- 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) Boehringer Mannheim Accu-Chek II Freedom: named in the summary without a submission number

## Recalls of this device
- May 13, 2009 · Not classified · Z-1592-2009: The lancet cap may be missing, which could result in an unintended lancet stick to the user.
- Jun 22, 2006 · Not classified · Z-1371-06: 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-1370-06: 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.

## Indications for use
Designed for testing glucose in whole blood by visually impaired persons with diabetes.

Source page: https://510kreport.com/device/K982079
Methodology: https://510kreport.com/methodology