# K152693: CLEARSIGN II Amplifier 40 Channels, CLEARSIGN II Amplifier 80 Channels, CLEARSIGN II Amplifier 120 Channels, CLEARSIGN II Amplifier 160 Channels

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corporation
- Decided: Oct 21, 2015 after 30 days
- Product code: DRQ (Amplifier And Signal Conditioner, Transducer Signal)
- Device class: 2
- Regulation: 21 CFR 870.2060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K913875 (1991). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150235: CLEARSIGN II Amplifier, 40 channels, CLEARSIGN II Amplifier, 80 channels, CLEARSIGN II Amplifier, 120 channels, CLEARSIGN II Amplifer, 160 channels, Boston Scientific Corporation (2015)

## Indications for use
The CLEARSIGN II Amplifier is intended to amplify and condition electrocardiographic signals of biologic origin and pressure transducer input, transmitting this information to a host computer (the LabSystem PRO EP Recording System) that can record and display the information.

Source page: https://510kreport.com/device/K152693
Methodology: https://510kreport.com/methodology