# K071755: Falck Applanation Tonometer (FAT2)

- Pathway: 510(k) (Traditional)
- Applicant: Falck Medical, Inc.
- Decided: Jun 3, 2008 after 341 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: 1 generation back to K981432 (1999). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981432: Goldman Manual Tonometer, Golden Vision, Inc. (1999) Summary page 1.
- K010998: Langham Ocular Blood Flow (Obf) Tonograph/Tonometer Model 201, Langham Ophthalmic Technologies (2001) Summary page 1.

## Most influential descendants
- K151491: Falck Medical Multifunction Tonometer, FAT1 (2016), 0 descendants of its own

## Indications for use
The Falck Medical Applanation Tonometer Model 2 (FAT 2) is indicated in the measurement of intraocular pressure and ocular pulsatile amplitude.

Source page: https://510kreport.com/device/K071755
Methodology: https://510kreport.com/methodology