# HKX: Tonometer, Ac-Powered

- Device class: 2; regulation: 21 CFR 886.1930; FDA's rule: 510(k) required
- FDA decisions: 58
- 510(k) review time 2021–2025: median 188 days (middle half 117–258)
- Recalls: 0 (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)
- 2009: 1
- 2010: 1
- 2011: 1
- 2012: 1
- 2015: 1
- 2017: 1
- 2018: 1
- 2019: 3
- 2023: 1
- 2025: 1

## Most-cited predicates
- K093298: Pulsair Intellipuff, Pulsair Desktop Model 2414-P-2001, 2417-P-2000 (2010), cited by 2
- K913189: Nidek Model NT-1000 (1991), cited by 2
- K143086: VX120 Ophthalmic Diagnostic Device (2015), cited by 2
- K023816: Canon Full Auto Tonometer TX-F (2002), cited by 2
- K180820: Tono Vue Non-Contact Tonometer (2018), cited by 2
- K021937: TGDC-01 Pra (2002), cited by 2
- K943939: Non-Contact Tonometer T-2 (1995), cited by 2
- K870750: Keeler Pulsair Non Contact Tonometer (1987), cited by 1
- K010998: Langham Ocular Blood Flow (Obf) Tonograph/Tonometer Model 201 (2001), cited by 1
- K162067: VX130 Ophthalmic Diagnostic Device (2017), cited by 1

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