# DEN100002: Infrascanner, Model 1000

- Pathway: De Novo (Post-NSE)
- Applicant: Infrascan, Inc.
- Decided: Dec 13, 2011 after 614 days
- Product code: OPT (Infrared Hematoma Detector)
- Device class: 2
- Regulation: 21 CFR 882.1935
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K120949: Infrascanner (2013), 3 descendants of its own
- K200203: Infrascanner (2020), 2 descendants of its own
- K211617: Infrascanner (2022), 1 descendant of its own
- K241389: Infrascanner Model 2500 (Model 2500) (2024), 0 descendants of its own

Source page: https://510kreport.com/device/DEN100002
Methodology: https://510kreport.com/methodology