# K181269: iCertainty

- Pathway: 510(k) (Traditional)
- Applicant: Rfpi
- Decided: Dec 14, 2018 after 214 days
- Product code: DPW (Flowmeter, Blood, Cardiovascular)
- Device class: 2
- Regulation: 21 CFR 870.2100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K905232 (1991). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120884: Pericam Psi, Perimed AB (2012) Summary page 4.

## Indications for use
The iCertainty System is intended for non-invasive two-dimensional imaging as an adjunctive method for evaluation of blood flow distribution (flow and perfusion) in tissues, up to a depth of 4-5mm.

Source page: https://510kreport.com/device/K181269
Methodology: https://510kreport.com/methodology