# K031997: Mallinckrodt Dar TY-Care / TY-Care Exel Closed  Suction System

- Pathway: 510(k) (Traditional)
- Applicant: Mallinckrodt Dar S.R.L.
- Decided: Nov 25, 2003 after 151 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
Longest line of descent: 1 generation back to K873810 (1987). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972258: HI-Care Closed Suction System, Mallinckrodt Medical (1997) Summary page 1.
- K974630: 72 Hour Use Trach Care with Microban, Ballard Medical Products (1998) Summary page 1.
- K964369: Trach Care Set with Microban, Ballard Medical Products (1997) Summary page 1.
- K873810: Safety Shield Suction Catheter, Ballard Medical Products (1987) Summary page 1.

## Indications for use
This closed suction system is indicated for endotracheal / tracheostomy suction of adult and pediatric intubated patients (including neonates). This device is intended for single use only.

Source page: https://510kreport.com/device/K031997
Methodology: https://510kreport.com/methodology