# K021937: TGDC-01 Pra

- Pathway: 510(k) (Traditional)
- Applicant: Truevision Instruments
- Decided: Oct 11, 2002 after 121 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
Longest line of descent: 1 generation back to K943939 (1995). 2 ancestors in all.
11 later devices descend from it; 2 cite it directly.
0 of 14 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 2.
- K943939: Non-Contact Tonometer T-2, Canon, Inc. (1995) Summary page 2.

## 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
Quick and accurate measurement of IOP in various situations independent of place and time is the dream of every ophthalmologist. Today the portable tonometer TGDc-01 “PRA gives you that capability. This new IOP measuring method through the eyelid in the sclera area, unique to our device, eliminates completely any effect on the mucous eye membrane. Painless diagnosticswithout anesthetics and antiseptics Elimination of infection risk Measuring results independent of cornea’s crookedness Evaluation of IOP in patients after any operations on cornea IOP measurement in children Monitoring of Glaucoma treatment

Source page: https://510kreport.com/device/K021937
Methodology: https://510kreport.com/methodology