# K141255: Simex Subglottic Aspiration System

- Pathway: 510(k) (Traditional)
- Applicant: Simex Medizintechnik GmbH
- Decided: Sep 22, 2014 after 131 days
- Product code: BTA (Pump, Portable, Aspiration (Manual Or Powered))
- Device class: 2
- Regulation: 21 CFR 878.4780
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K945062 (1995). 16 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061205: Medela Vario 8/18/CI Secretion & Surgical Aspirator, Medela AG (2006) Summary page 4.
- K113291: Simex Negative Pressure Wound Therapy Powered Suction Pumps Series: Sim-EX200 and Sim-EX300, Simex Medizintechnik GmbH (2012) Summary page 4.
- K061133: Simex Suction Pump, Models AC20, AC20K, AC30, DC20, DC30 and DC30S, Novaspine, LLC (2006) Summary page 4.

## Most influential descendants
- K150157: AnapnoGuard 100 Respiratory Guard System (2016), 2 descendants of its own
- K180991: AG 100s (2018), 1 descendant of its own
- K221477: AG100s (2022), 0 descendants of its own

## Indications for use
The SIMEX Subglottic Aspiration System models cuff M and cuff S are indicated for vacuum suction, extraction, aspiration and removal of surgical fluids, tissue (including bone), bodily fluids or infectious materials from wounds or from patient's airway or respiratory system, either during surgery or at the patient's bedside. Generally, the SIMEX Subglottic Aspiration System is intended for removing subglottic secretions from the patient's airway above the endotracheal or tracheal cuff using intermittent suction when used in ICU and acute care settings where the duration of mechanical ventilation is limited to a maximum of 4 weeks.

Source page: https://510kreport.com/device/K141255
Methodology: https://510kreport.com/methodology