510(k) · Cleared
ClearedBorealis Amplifier (Clearsign), Model 2001232 160 Channel Version, 2001267 80 Channel Version, 2001268 40 Channel Versio
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc. · DRQ Amplifier And Signal Conditioner, Transducer Signal
Cleared on May 27, 2005 as substantially equivalent to K913875 (Bard Electrophysiology, 1991) after a 144-day review. Its family tree reaches back 1 generation to 1991. 2 later devices descend from it.
- Decided
- May 27, 2005
- Review
- 144 days
- Class
- Class II
- Product code
- DRQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K913875 (1991). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK913875 Bard (R) Biopotential Amplifier IIBard Electrophysiology · 1991
- This deviceK050006 Borealis Amplifier (Clearsign), Model 2001232 160 Channel Version…C.R. Bard, Inc. · 2005
- Descendant · cites it directly · 1 of its ownK150235 CLEARSIGN II Amplifier, 40 channels, CLEARSIGN II Amplifier, 80…Boston Scientific Corporation · 2015 · Recalled
- Descendant · 2 generations on · 0 of its ownK152693 CLEARSIGN II Amplifier 40 Channels, CLEARSIGN II Amplifier 80…Boston Scientific Corporation · 2015
Most influential descendants
Showing 2 of 2 · See all- K150235CLEARSIGN II Amplifier, 40 channels, CLEARSIGN II Amplifier, 80 channels, CLEARSIGN II…Boston Scientific Corporation · 2015 · cites it directly1descendant
- K152693CLEARSIGN II Amplifier 40 Channels, CLEARSIGN II Amplifier 80 Channels, CLEARSIGN II…Boston Scientific Corporation · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K913875 | Bard (R) Biopotential Amplifier II | Bard Electrophysiology | 1991 | — |
| 0 (this device) | K050006 | Borealis Amplifier (Clearsign), Model 2001232 160 Channel Version, 2001267 80… | C.R. Bard, Inc. | 2005 | — |
| +1 | K150235 | CLEARSIGN II Amplifier, 40 channels, CLEARSIGN II Amplifier, 80 channels… | Boston Scientific Corporation | 2015 | 1 |
| +2 | K152693 | CLEARSIGN II Amplifier 40 Channels, CLEARSIGN II Amplifier 80 Channels… | Boston Scientific Corporation | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DRQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K913875 | Bard (R) Biopotential Amplifier IISummary page 1…lassification Name: Programmable Amplifier 6.3 Predicate Device Name(s) C.R. Bard, Inc.: Bard Biopotentiai Amplifier Ii, K91 3875, November 27, 1991 6.4 Device Description The Borealis Amplifier is a medical device intended to collect, amplif… | 1991 |
| * | — | STAMP Amplifier Named without a submission number |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150235 | CLEARSIGN II Amplifier, 40 channels, CLEARSIGN II Amplifier, 80 channels, CLEARSIGN II… | 2015 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K150235 (Boston Scientific Corporation, 2015) has gone furthest, with 1 descendant of its own.
How does its category compare?
All DRQ devicesDRQ Amplifier And Signal Conditioner, Transducer Signal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DRQ
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · DRQ
Too few DRQ 510(k)s in any year since 2007 to give a median.
Recalls per year · DRQ
No recall names DRQ since 2007.
Adverse event reports per year · DRQ
3in 2025
MAUDE reports naming product code DRQ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 2 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 1 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 5 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 0 | — | 0 | 6 |
| 2023 | 0 | — | 0 | 8 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050006 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050006: Borealis Amplifier (Clearsign), Model 2001232 160 Channel Version, 2001267 80 Channel Version, 2001268 40 Channel Versio.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050006
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026