510(k) Report

510(k) · Cleared

Cleared

Bard (R) Biopotential Amplifier II

K913875510(k) TraditionalCleared Nov 27, 199190-day reviewClass II21 CFR 870.2060

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Bard Electrophysiology · DRQ Amplifier And Signal Conditioner, Transducer Signal

Cleared on Nov 27, 1991 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.

Decided
Nov 27, 1991
Review
90 days
Class
Class II
Product code
DRQ
Recalls
None
Predicates
0

3 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2005: 1 descendant cleared2015: 2 descendants cleared1990200020102020
  1. This deviceK913875 Bard (R) Biopotential Amplifier IIBard Electrophysiology · 1991
  2. Descendant · cites it directly · 2 of its ownK050006 Borealis Amplifier (Clearsign), Model 2001232 160 Channel Version…C.R. Bard, Inc. · 2005
  3. Descendant · 2 generations on · 1 of its ownK150235 CLEARSIGN II Amplifier, 40 channels, CLEARSIGN II Amplifier, 80…Boston Scientific Corporation · 2015 · Recalled
  4. Descendant · 3 generations on · 0 of its ownK152693 CLEARSIGN II Amplifier 40 Channels, CLEARSIGN II Amplifier 80…Boston Scientific Corporation · 2015

Most influential descendants

Showing 3 of 3 · See all
  • K050006Borealis Amplifier (Clearsign), Model 2001232 160 Channel Version, 2001267 80 Channel…C.R. Bard, Inc. · 2005 · cites it directly2descendants
  • K150235CLEARSIGN II Amplifier, 40 channels, CLEARSIGN II Amplifier, 80 channels, CLEARSIGN II…Boston Scientific Corporation · 2015 · 2 generations on1descendant
  • K152693CLEARSIGN II Amplifier 40 Channels, CLEARSIGN II Amplifier 80 Channels, CLEARSIGN II…Boston Scientific Corporation · 2015 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K913875Bard (R) Biopotential Amplifier IIBard Electrophysiology1991—
+1K050006Borealis Amplifier (Clearsign), Model 2001232 160 Channel Version, 2001267 80…C.R. Bard, Inc.2005—
+2K150235CLEARSIGN II Amplifier, 40 channels, CLEARSIGN II Amplifier, 80 channels…Boston Scientific Corporation20151
+3K152693CLEARSIGN II Amplifier 40 Channels, CLEARSIGN II Amplifier 80 Channels…Boston Scientific Corporation2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
201520
FIG. 1 — Lineage of K913875, 1991–2015Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (3)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K050006Borealis Amplifier (Clearsign), Model 2001232 160 Channel Version, 2001267 80 Channel…C.R. Bard, Inc.20052

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?

  • Of its descendants, K050006 (C.R. Bard, Inc., 2005) has gone furthest, with 2 descendants of its own.

How does its category compare?

All DRQ devices

DRQ 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

2015: 22017: 1
2007high 2 (2015) · low 0 (2007)2026

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

2015: 12016: 22017: 32018: 12020: 52021: 42022: 62023: 82024: 52025: 3
2007high 8 (2023) · low 0 (2007)2025

MAUDE reports naming product code DRQ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20152—01
20160—02
20171—03
20180—01
20190—00
20200—05
20210—04
20220—06
20230—08
20240—05
20250—03
20260—0—

More from Bard Electrophysiology

3 FDA decisions under this applicant name. See the company

  • K042105Clipper Diagnostic Electrode CatheterBard Electrophysiology · 2004
  • K893611Bard Plaque Electrode ArrayBard Electrophysiology · 1989

Recent decisions in DRQ

The DRQ category page

  • K172216ACIST RXi Mini SystemAcist Medical Systems, Inc. · 2017
  • K152693CLEARSIGN II Amplifier 40 Channels, CLEARSIGN II Amplifier 80 Channels, CLEARSIGN II Amplifier 120 Channels…Boston Scientific Corporation · 2015
  • K150235CLEARSIGN II Amplifier, 40 channels, CLEARSIGN II Amplifier, 80 channels, CLEARSIGN II Amplifier, 120…Boston Scientific Corporation · 20151 recall
  • K050006Borealis Amplifier (Clearsign), Model 2001232 160 Channel Version, 2001267 80 Channel Version, 2001268 40…C.R. Bard, Inc. · 2005
  • K050974Draeger Medical Information Bus (Mib, Mib II, Mib Duo) Protocol ConvertersDraeger Medical Systems, Inc. · 2005

https://510kreport.com/device/K913875 · printed Nov 6, 2026

Cite this page

510(k) Report. “K913875: Bard (R) Biopotential Amplifier II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K913875

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026