# K062610: Care-E-Vac 3

- Pathway: 510(k) (Special)
- Applicant: Ohio Medical Corporation
- Decided: Sep 28, 2006 after 23 days
- Product code: BTA (Pump, Portable, Aspiration (Manual Or Powered))
- Device class: 2
- Regulation: 21 CFR 878.4780
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K926566 (1993). 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)
- K926566: Care-E-Vac, Aeros Instruments, Inc. (1993) Summary page 1.

## Recalls of this device
- Aug 14, 2018 · Class II · Z-2995-2018: The care-e-vac(R)3 Battery/AC Powered Portable Aspirator battery terminal may come in contact with the pump causing an electric short leading to damage to wiring and resulting in loss of function or a
- Nov 8, 2010 · Not classified · Z-0833-2011: The D-14 diode on the circuit board may fail, resulting in a damaged, overheated circuit board. Also a screw used to attach one of the feet of the unit may damage the battery inside the device if the 

## Indications for use
The device is a portable aspirator which uses suction as a means to withdraw fluids or foreign bodies from a patient. The primary intended use of the care-e-vac 3 is as an aspirator to be used to help evacuate saliva, mucous, vomit or other aspirant from the mouth and or airway to allow adequate respiration or ventilation of the patient.

Source page: https://510kreport.com/device/K062610
Methodology: https://510kreport.com/methodology