# JHI: Visual, Pregnancy Hcg, Prescription Use

- Device class: 2; regulation: 21 CFR 862.1155; FDA's rule: 510(k) required
- FDA decisions: 376
- 510(k) review time 2021–2025: median 242 days (middle half 137–346)
- Recalls: 41 (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)
- 2010: 1
- 2012: 2
- 2013: 2
- 2014: 2
- 2016: 1
- 2017: 1
- 2018: 1
- 2022: 1
- 2024: 1
- 2026: 1

## Most-cited predicates
- K020801: Quickvue One-Step HCG-Combo (2002), cited by 3
- K993065: Acon Combo Pregnancy (1999), cited by 3
- K953383: Wyntek Osom HCG-Urine Test (1995), cited by 3
- K952319: Contrast & Rapid HCG Urine/Serum TST (1995), cited by 2
- K990578: Osom Card II HCG-Urine Test, Model 102 (1999), cited by 2
- K203272: Alltest Pregnancy Rapid Combo Test Cassette (2022), cited by 2
- K964461: One -Step Urine/Serum Combo Pregnancy Card Test (1997), cited by 2
- K172322: Atellica IM Total hCG (ThCG) (2018), cited by 2
- K945951: Quikpac II, One Step HCG Combo Kit (1995), cited by 2
- K993203: Acon One Step Pregnancy Test Strip (Urine) (1999), cited by 2

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