# K050006: Borealis Amplifier (Clearsign), Model 2001232 160 Channel Version, 2001267 80 Channel Version, 2001268 40 Channel Versio

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: May 27, 2005 after 144 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: 1 generation back to K913875 (1991). 1 ancestor in all.
2 later devices descend 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)
- K913875: Bard (R) Biopotential Amplifier II, Bard Electrophysiology (1991) Summary page 1.
- (no number) STAMP Amplifier: named in the summary without a submission number

## Most influential descendants
- K150235: CLEARSIGN II Amplifier, 40 channels, CLEARSIGN II Amplifier, 80 channels, CLEARSIGN II Amplifier, 120 channels, CLEARSIGN II Amplifer, 160 channels (2015), 1 descendant of its own
- 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

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

Source page: https://510kreport.com/device/K050006
Methodology: https://510kreport.com/methodology