# CAZ: Anesthesia Conduction Kit

- Device class: 2; regulation: 21 CFR 868.5140; FDA's rule: 510(k) required
- FDA decisions: 156
- 510(k) review time 2021–2025: median 267 days (middle half 231–340)
- Recalls: 158 (11 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2011: 1
- 2012: 9
- 2015: 1
- 2016: 2
- 2019: 1
- 2020: 1
- 2021: 1
- 2022: 1
- 2023: 1
- 2026: 1

## Most-cited predicates
- K013041: Plexolong Sets (2002), cited by 10
- K813186: Perfix Set for Epidural Anesthesia W/Tuo (1981), cited by 9
- K033018: Stimulong Plus Catheter Set Model, Various (2004), cited by 8
- K103658: Flextip Plus Closed Tip Epidural Catherter (2012), cited by 4
- K030937: Stimucath Continuous Nerve Block Set, Models AB-02030, AB-02060, AB-02090, AB-02030-PK, AB-02060-PK, AB-02090-PK (2003), cited by 4
- K061737: Loss of Resistance Syringe (2006), cited by 4
- K925902: B-D Loss of Resistance Syringe (1993), cited by 3
- K043130: Modification to Pajunk Stimulong Plus Catheter Sets (2004), cited by 3
- K994059: Cla Kit (Continuous Local Anesthesia), Model 551-17, 551-10, 551-07 (2000), cited by 3
- K932249: Durasafe B-D Combined Spinal Epidural Anesthesia (1993), cited by 3

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