# DQX: Wire, Guide, Catheter

- Device class: 2; regulation: 21 CFR 870.1330; FDA's rule: 510(k) required
- FDA decisions: 769
- 510(k) review time 2021–2025: median 162 days (middle half 99–248)
- Recalls: 174 (8 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: 19
- 2018: 19
- 2019: 13
- 2020: 14
- 2021: 6
- 2022: 15
- 2023: 10
- 2024: 11
- 2025: 10
- 2026: 12

## Most-cited predicates
- K022762: Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000, AG143000, AG141002, AG141010, AG14M060 & AG14M050 (2002), cited by 23
- K041531: Asahi Ptca Guide Wire Confianza Pro (2004), cited by 12
- K031277: Jowire Asahi Ptca Catheter Guide Wires, Models AG145300,141300,142300,132200,14M350,14M345,14M360,143390,141002 (2003), cited by 12
- K863138: Terumo Radifocus Guide Wire (1986), cited by 12
- K011084: Mandrel Guidewire Assembly (2001), cited by 11
- K810675: Arrow Radial Artery Catheterization Set (1981), cited by 9
- K971254: Transend EX Platinum Guidewire (1997), cited by 9
- K052339: Asahi Ptca Guide Wire (2005), cited by 9
- K052022: Asahi Ptca Guide Wire Fielder (2005), cited by 8
- K163426: ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire Extension (2017), cited by 7

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