# K974630: 72 Hour Use Trach Care with Microban

- Pathway: 510(k) (Traditional)
- Applicant: Ballard Medical Products
- Decided: Mar 11, 1998 after 89 days
- Product code: CAH (Filter, Bacterial, Breathing-Circuit)
- Device class: 2
- Regulation: 21 CFR 868.5260
- 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 summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K956436: TRACH CARE® Set with MICROBAN®. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Most influential descendants
- K031997: Mallinckrodt Dar TY-Care / TY-Care Exel Closed  Suction System (2003), 0 descendants of its own

## Indications for use
As with the great majority of other ET suction catheters, the indication for endotracheal suctioning is to provide a patent airway by removing excess fluids, secretions, exudate and transudate through the artificial airway. These include patients with indwelling oral or nasal endotracheal tubes, and tracheostomy tubes. This system applies to intubated patients requiring a full range of respiration and ventilatory support. They may be spontaneously breathing, on mechanical ventilation, or partially supported by mechanical devices. The TRACH CARE® closed suction system, as well as other suction catheters, can also be used for saline lavage and surfactant delivery to the distal airway. The closed system device allows for multiple suction episodes utilizing the same catheter. The protective sleeve of the closed system 1solates the flora from the patient’s secretions, thus reducing the risk of cross-contamination to health care providers and other patients.

Source page: https://510kreport.com/device/K974630
Methodology: https://510kreport.com/methodology