510(k) · Cleared
Recalled · Class II · 2015CLEARSIGN II Amplifier, 40 channels, CLEARSIGN II Amplifier, 80 channels, CLEARSIGN II Amplifier, 120 channels, CLEARSIGN II Amplifer, 160 channels
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corporation · DRQ Amplifier And Signal Conditioner, Transducer Signal
Cleared on Apr 22, 2015 as substantially equivalent to K050006 (C.R. Bard, Inc., 2005) after a 79-day review. Its family tree reaches back 2 generations to 1991. 1 later device descends from it. It has been recalled once.
- Decided
- Apr 22, 2015
- Review
- 79 days
- Class
- Class II
- Product code
- DRQ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K913875 (1991). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK913875 Bard (R) Biopotential Amplifier IIBard Electrophysiology · 1991
- 1 generation backK050006 Borealis Amplifier (Clearsign), Model 2001232 160 Channel Version…C.R. Bard, Inc. · 2005
- This deviceK150235 CLEARSIGN II Amplifier, 40 channels, CLEARSIGN II Amplifier, 80…Boston Scientific Corporation · 2015
- Descendant · cites it directly · 0 of its ownK152693 CLEARSIGN II Amplifier 40 Channels, CLEARSIGN II Amplifier 80…Boston Scientific Corporation · 2015
Most influential descendants
Showing 1 of 1 · See all- K152693CLEARSIGN II Amplifier 40 Channels, CLEARSIGN II Amplifier 80 Channels, CLEARSIGN II…Boston Scientific Corporation · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K913875 | Bard (R) Biopotential Amplifier II | Bard Electrophysiology | 1991 | — |
| −1 | K050006 | Borealis Amplifier (Clearsign), Model 2001232 160 Channel Version, 2001267 80… | C.R. Bard, Inc. | 2005 | — |
| 0 (this device) | K150235 | CLEARSIGN II Amplifier, 40 channels, CLEARSIGN II Amplifier, 80 channels… | Boston Scientific Corporation | 2015 | — |
| +1 | 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 | 1 | 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? (1)
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 |
|---|---|---|---|
| * | K050006 | Borealis Amplifier (Clearsign), Model 2001232 160 Channel Version, 2001267 80 Channel…Summary page 4…ransducer Signal Amplifier and Conditioner Classification Class II, 21 CFR Part 870.2060 Predicate CLEARSIGN (Borealis) Amplifier Devices K050006, cleared May 27, 2005 Device The LabSystem Pro (LS PRO) EP Recording System (K141185) with Description CL… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152693 | CLEARSIGN II Amplifier 40 Channels, CLEARSIGN II Amplifier 80 Channels, CLEARSIGN II… | 2015 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 2, 2015 | Class II | Z-1817-2015 | Software design | 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 to a variable degree, with the result… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 3 companies; a new generation was cleared every 13.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K152693 (Boston Scientific Corporation, 2015) has gone furthest, with 0 descendants 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. 2015, this device’s year, is highlighted.
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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150235 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150235: CLEARSIGN II Amplifier, 40 channels, CLEARSIGN II Amplifier, 80 channels, CLEARSIGN II Amplifier, 120 channels, CLEARSIGN II Amplifer, 160 channels.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150235
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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