# HKY: Tonometer, Manual

- Device class: 2; regulation: 21 CFR 886.1930; FDA's rule: 510(k) required
- FDA decisions: 56
- 510(k) review time 2021–2025: median 165 days (middle half 112–190)
- Recalls: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2015: 2
- 2016: 3
- 2017: 2
- 2018: 3
- 2019: 1
- 2020: 2
- 2021: 1
- 2022: 2
- 2023: 1
- 2024: 3

## Most-cited predicates
- K981432: Goldman Manual Tonometer (1999), cited by 10
- K133234: T-Type D-Kat, R-Type D-Kat (2014), cited by 4
- K142179: D-Kat Z-Ype (2014), cited by 2
- K153694: Icare ic100 (2016), cited by 2
- K063873: Icare Tonometer TA01I (2007), cited by 2
- K173904: CATS Tonometer Prism (2018), cited by 2
- K093445: Keeler Applanation Tonometer; T-Type Kat, K-Type Kat, (Kat) (2010), cited by 2
- K220852: iCare IC200 (2022), cited by 1
- K071755: Falck Applanation Tonometer (FAT2) (2008), cited by 1
- K190316: Icare ic200 (2020), cited by 1

Source page: https://510kreport.com/product-code/HKY
Data by year (CSV): https://510kreport.com/product-code/HKY.csv