# K852608: Spectra 400 Extended Surveillance & Alert System

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems Information Technologies
- Decided: Sep 27, 1985 after 100 days
- Product code: HGM (System, Monitoring, Perinatal)
- Device class: 2
- Regulation: 21 CFR 884.2740
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
32 later devices descend from it; 4 cite it directly.
0 of 33 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
- K991905: Corometrics Model 171 and 172 Fetal Monitor (1999), 16 descendants of its own
- K040903: Cadence, Models 2001 and 2002 (2004), 12 descendants of its own
- K073221: Cadence II (2007), 11 descendants of its own
- K991739: Corometrics 120 Series Maternal/Fetal Monitor (1999), 10 descendants of its own
- K963608: Quantitative Sentinel System (1997), 10 descendants of its own

Source page: https://510kreport.com/device/K852608
Methodology: https://510kreport.com/methodology