# K032967: Pascal Dynamic Contour Tonometer

- Pathway: 510(k) (Traditional)
- Applicant: Smt Swiss Microtechnology AG
- Decided: Nov 14, 2003 after 52 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
No predicates in its family tree.
9 later devices descend from it; 1 cites it directly.
0 of 10 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
- K063873: Icare Tonometer TA01I (2007), 8 descendants of its own
- K153694: Icare ic100 (2016), 4 descendants of its own
- K190316: Icare ic200 (2020), 2 descendants of its own
- K163343: Icare HOME tonometer (2017), 2 descendants of its own
- K220852: iCare IC200 (2022), 1 descendant of its own

## Indications for use
The PASCALTM Dynamic Contour Tonometer is a diagnostic device that serves for measuring intraocular pressure (IOP), according to the Contour Tonometry method. The device is also capable of measuring short term pressure fluctuations. PASCALTM is specially indicated in Glaucoma.

Source page: https://510kreport.com/device/K032967
Methodology: https://510kreport.com/methodology