# K151491: Falck Medical Multifunction Tonometer, FAT1

- Pathway: 510(k) (Traditional)
- Applicant: Falck Medical, Inc.
- Decided: Jan 15, 2016 after 226 days
- Product code: HKY (Tonometer, Manual)
- Device class: 2
- Regulation: 21 CFR 886.1930
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K981432 (1999). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071755: Falck Applanation Tonometer (FAT2), Falck Medical, Inc. (2008) Summary page 4.
- K002395: Model 30 Classic Pneumatonometer, Xomed, Inc. (2000) Summary page 4.

## Indications for use
The Falck Medical Multi-function Tonometer (FAT1) is indicated for the measurement of intraocular pressure, ocular pulsatile amplitude, force (Ophthalmodynamometry) and estimating conventional outflow facility with calibrated force application (Indentation Tonography).

Source page: https://510kreport.com/device/K151491
Methodology: https://510kreport.com/methodology