# K150235: CLEARSIGN II Amplifier, 40 channels, CLEARSIGN II Amplifier, 80 channels, CLEARSIGN II Amplifier, 120 channels, CLEARSIGN II Amplifer, 160 channels

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corporation
- Decided: Apr 22, 2015 after 79 days
- Product code: DRQ (Amplifier And Signal Conditioner, Transducer Signal)
- Device class: 2
- Regulation: 21 CFR 870.2060
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K913875 (1991). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050006: Borealis Amplifier (Clearsign), Model 2001232 160 Channel Version, 2001267 80 Channel Version, 2001268 40 Channel Versio, C.R. Bard, Inc. (2005) Summary page 4.

## Most influential descendants
- K152693: CLEARSIGN II Amplifier 40 Channels, CLEARSIGN II Amplifier 80 Channels, CLEARSIGN II Amplifier 120 Channels, CLEARSIGN II Amplifier 160 Channels (2015), 0 descendants of its own

## Recalls of this device
- Jun 2, 2015 · Class II · Z-1817-2015: Boston Scientific has received complaints indicating that, when using the blood pressure (BP) channels on the CLEARSIGN II Amplifier, the surface Electrocardiogram (ECG) channels become over-written t

## 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/K150235
Methodology: https://510kreport.com/methodology