# K102835: Vital Signs Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Edan Instruments, Inc.
- Decided: Dec 27, 2010 after 89 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 3 cite it directly.
0 of 7 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
- K120144: Vital Signs Monitor (2012), 2 descendants of its own
- K131818: Vital Signs Monitor (2013), 1 descendant of its own
- K113653: Patient Monitor (2012), 1 descendant of its own
- K180380: vital signs monitor (2018), 0 descendants of its own
- K123048: Patient Monitor Models PM-2000A, PM-2000A+, PM-2000A Pro (2013), 0 descendants of its own

Source page: https://510kreport.com/device/K102835
Methodology: https://510kreport.com/methodology