# K052286: Deutsch Anti-Blockage Wound Drain

- Pathway: 510(k) (Traditional)
- Applicant: The Catheter Exchange, Inc.
- Decided: Oct 21, 2005 after 60 days
- Product code: GBX (Catheter, Irrigation)
- Device class: 1
- Regulation: 21 CFR 878.4200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K973703 (1997). 2 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973703: Jackson-Pratt Hemaduct Wound Drain, Jackson-Pratt Gold Hemaduct Wound Drain, Allegiance Healthcare Corp. (1997) Summary page 1.
- K993592: Axiom Multipurpose Wound Drain, Axiom Medical, Inc. (2000) Summary page 1.

## Most influential descendants
- K093565: Pleuraflow Catheter System (2010), 5 descendants of its own
- K150042: PleuraFlow System (2015), 4 descendants of its own
- K163139: PleuraFlow System with FlowGlide (2016), 2 descendants of its own
- K191733: The ZIP Accessory Shuttle for PleuraFlow System (2019), 0 descendants of its own
- K182067: PleuraFlow System with FlowGlide Extra Drainage Length (2018), 0 descendants of its own

## Indications for use
The anti-clog drain is indicated for use as an adjunctive device during open surgical procedures in order to prevent fluid accumulation within the operative site after closure of the surgical wound. The device is inserted through the skin adjacent to open surgical incision. The distal end of the drain is positioned within the operative site prior to repair of the incision. The device's proximal end is attached to an appropriate suction source in order to allow efflux of bloody, rosanguinous, chylous, purulent fluid, intestinal, and/or other fluids from the operative site that could impair surgical wound healing. The device is indicated for use in abdominal, thoracic, head and neck, gynecological, urological, spinal, and orthopedic surgical procedures.

Source page: https://510kreport.com/device/K052286
Methodology: https://510kreport.com/methodology