# K955831: Argyle Aspr-Care Closed Suction System

- Pathway: 510(k) (Traditional)
- Applicant: Sherwood Medical Co.
- Decided: Mar 28, 1996 after 93 days
- Product code: BSY (Catheters, Suction, Tracheobronchial)
- Device class: 1
- Regulation: 21 CFR 868.6810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Ballard Medical Products Trach Care™ Closed Suction System: named in the summary without a submission number
- (no number) Concord/Portex Steri-Cath™ Closed Suction System: named in the summary without a submission number
- (no number) Portex Fiberoptic Swivel Adapter: named in the summary without a submission number
- (no number) Argyle® Lukens Specimen Container: named in the summary without a submission number

## Most influential descendants
- K972139: Aspr-Care Closed System,Dual Swivel Piece T,Sheathed Suction Catheter,Bronchosope Adapter,in-Line Specimen Trap (1997), 0 descendants of its own

## Indications for use
The device is intended to be used in critical care units to aspirate secretions from patient airways who have endotracheal or tracheostomy tubes and require mechanical ventilation. The system allow for the insertion and withdrawal of a suction catheter into the artificial airway without disconnecting the patient from the ventilator circuit. The components of this system are sterile, single patient use, and disposable.

Source page: https://510kreport.com/device/K955831
Methodology: https://510kreport.com/methodology