# DWM: Apparatus, Suction, Patient Care

- Device class: 2; regulation: 21 CFR 870.5050; FDA's rule: 510(k) required
- FDA decisions: 19
- 510(k) review time 2021–2025: median 377 days (middle half 288–466)
- Recalls: 2 (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)
- 2011: 1
- 2012: 2
- 2013: 1
- 2015: 1
- 2016: 1
- 2017: 1
- 2019: 1
- 2020: 1
- 2021: 1
- 2023: 1

## Most-cited predicates
- K110409: Aspira Pleural Drainage System (2011), cited by 4
- K051084: Denver Pleurx Drainage Kit and Denver Pleurx Vacuum Bottle with Drainage Line (2005), cited by 3
- K052436: Pleurx Pleural Catheter Kit, Model 50-7000 (2005), cited by 3
- K011831: Modification to Pleurx Pleural Catheter and Drainage Kits (2001), cited by 2
- K123033: Rocket Ipc Insertion Pack, Rocket Ipc Mini Insertion Set, Rocket Ipc Dressing Pack and Bottle Set, Rocket Ipc Drainage B (2013), cited by 2
- K010642: Pleurx Pleural Catheter and Drainage Kits (2001), cited by 2
- K112831: Pleurx Pleural Catheter Systems (2012), cited by 2
- K121849: Pleurx Pleural Catheter System, Pleurx Catheter Access Kit, Pleurx Catheter Insertion Stylet, Pleurx Integral Valved Pee (2012), cited by 1
- K141965: Pleurx Pleural Catheter System, Pleurx Catheter Access Kit (2015), cited by 1
- K093307: Asept Pleural Drainage System (2009), cited by 1

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