# K033179: Medela Clario Home Care Pump

- Pathway: 510(k) (Abbreviated)
- Applicant: Medela AG
- Decided: Oct 15, 2003 after 14 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: 1 generation back to K862569 (1986). 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)
- K983552: Basic, Median, Dominant, and Vario, Medela, Inc. (1999) Summary page 1.
- K862569: Heavy Duty (HD) Suction Units (W/Cannulas), Jedmed Instrument Co. (1986) Summary page 1.
- K941961: 605 Vacu-Max, Medical Industries America, Inc. (1995) Summary page 1.
- K932031: Ambu Portable Suction Unit, Ambu, Inc. (1995) Summary page 1.

## Indications for use
The Medela CLARIO Suction Pumps are indicated for aspiration and removal of secretions, bodily fluids and foreign objects from a patient's airway or respiratory support system in the nasal, pharyngeal and tracheal areas.

Source page: https://510kreport.com/device/K033179
Methodology: https://510kreport.com/methodology