# HAW: Neurological Stereotaxic Instrument

- Device class: 2; regulation: 21 CFR 882.4560; FDA's rule: 510(k) required
- FDA decisions: 426
- 510(k) review time 2021–2025: median 139 days (middle half 94–258)
- Recalls: 117 (9 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2017: 7
- 2018: 6
- 2019: 10
- 2020: 5
- 2021: 9
- 2022: 7
- 2023: 14
- 2024: 7
- 2025: 9
- 2026: 5

## Most-cited predicates
- K050438: Stealthstation System Update (2005), cited by 23
- K954276: Stealthstation (1996), cited by 23
- K040368: Vectorvision Hip 3.0 (2004), cited by 12
- K983831: VECTORVISION2 (1999), cited by 12
- K012380: Modification to: Stryker Navigation System, Stryker Fluoroscopy System,Virtual Fluoroscopy (2001), cited by 10
- K070106: VV Fluoro 3D (2007), cited by 10
- K021306: Vectorvision CT-Free Knee (2002), cited by 10
- K162309: StealthStation S8 System Platforms and StealthStation Cranial Software (2017), cited by 9
- K001284: Stealthstation System Goldeneye Micro-Magnetic Tracking System (2000), cited by 9
- K003347: Orthopilot (2001), cited by 9

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