# K972139: Aspr-Care Closed System,Dual Swivel Piece T,Sheathed Suction Catheter,Bronchosope Adapter,in-Line Specimen Trap

- Pathway: 510(k) (Traditional)
- Applicant: Davis & Geck, Inc.
- Decided: Sep 3, 1997 after 89 days
- Product code: BTM (Ventilator, Emergency, Manual (Resuscitator))
- Device class: 2
- Regulation: 21 CFR 868.5915
- 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 K955831 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955831: Argyle Aspr-Care Closed Suction System, Sherwood Medical Co. (1996) Summary page 1.

## Indications for use
The Device allows for the connection of 2 manual resuscitation bag without the disconnection of the ventilator circuit/system or the removal of the ASPR-Care™ CSS dual swivel T-piece connector.

Source page: https://510kreport.com/device/K972139
Methodology: https://510kreport.com/methodology