# DQK: Computer, Diagnostic, Programmable

- Device class: 2; regulation: 21 CFR 870.1425; FDA's rule: 510(k) required
- FDA decisions: 440
- 510(k) review time 2021–2025: median 113 days (middle half 69–172)
- Recalls: 72 (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: 7
- 2018: 14
- 2019: 15
- 2020: 16
- 2021: 16
- 2022: 19
- 2023: 21
- 2024: 13
- 2025: 22
- 2026: 23

## Most-cited predicates
- K092105: Radianalyzer Xpress (2009), cited by 8
- K180881: HemoSphere Advanced Monitor, HemoSphere Pressure Cable (2018), cited by 7
- K031561: Cardiosoft/Case Cardiac Testing System (2003), cited by 6
- K133916: Carto 3 EP Navigation System, Version 4.2 (2014), cited by 6
- K201446: HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module (2020), cited by 6
- K014108: Mac 5000 Ecg Analysis System (2002), cited by 6
- K213682: HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable, HemoSphere Pressure Cable, HemoSphere ClearSight Module, HemoSphere Technology Module, HemoSphere ForeSight Oximeter Cable, Acumen Hypotension Prediction Index Feature, Acumen Assisted Fluid Management Feature, Viewfinder Remote (2022), cited by 5
- K043604: Lifeshirt Real-Time with Vivomonitor Software (2005), cited by 5
- K201298: VX1 (2020), cited by 5
- K110878: Rhythmview (TM) (2011), cited by 5

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