# K010998: Langham Ocular Blood Flow (Obf) Tonograph/Tonometer Model 201

- Pathway: 510(k) (Traditional)
- Applicant: Langham Ophthalmic Technologies
- Decided: Jun 27, 2001 after 85 days
- Product code: HKX (Tonometer, Ac-Powered)
- 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
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K071755: Falck Applanation Tonometer (FAT2) (2008), 1 descendant of its own
- K151491: Falck Medical Multifunction Tonometer, FAT1 (2016), 0 descendants of its own

## Indications for use
The Langham Ocular Blood Flow (OBF) Mqdel 201 measures the intraocular pressure and the pulse amplitude.

Source page: https://510kreport.com/device/K010998
Methodology: https://510kreport.com/methodology