# PZR: Percutaneous Nerve Stimulator For Opioid Withdrawal

- Device class: 2; regulation: 21 CFR 882.5896; FDA's rule: 510(k) required
- FDA decisions: 8
- 510(k) review time 2021–2025: median 130 days (middle half 99–168)
- 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)
- 2017: 1
- 2018: 1
- 2021: 2
- 2022: 1
- 2023: 1
- 2024: 1
- 2025: 1

## Most-cited predicates
- DEN170018: NSS-2 System (2017), cited by 2
- K201873: Sparrow Therapy System (2021), cited by 2
- K211971: Drug Relief v1 (2021), cited by 1
- K173861: Drug Relief (2018), cited by 1
- K230796: Sparrow Ascent (2023), cited by 1

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