# K851172: Cobas Mira

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostic Systems, Inc.
- Decided: May 2, 1985 after 41 days
- Product code: JJF (Analyzer, Chemistry, Micro, For Clinical Use)
- Device class: 1
- Regulation: 21 CFR 862.2170
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 3 cite it directly.
0 of 6 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
- K040958: Prestige Models 24I and 400 and MGC Model 240 (2005), 2 descendants of its own
- K120591: Diamond Tokyo Boeki Ise Module Calibrator 1,2,1-2 (2012), 0 descendants of its own
- K110520: Biolis 12I (2012), 0 descendants of its own
- K070704: Trilogy Analyzer (2007), 0 descendants of its own
- K964409: HCL - 200 Biochemistry Analyzer (1997), 0 descendants of its own

Source page: https://510kreport.com/device/K851172
Methodology: https://510kreport.com/methodology