510(k) Report

510(k) · Cleared

Cleared

Era 3000; PA-2 IS-1 Adapter; EK-4-N Pacemaker Test Cable; Era 3000 Charger; Era 3000 Battery (Type 2); NK-11 Power Supp.

K022360510(k) TraditionalCleared Jan 27, 2003192-day reviewClass II21 CFR 870.3720

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

Biotronik, Inc. · DTA Tester, Pacemaker Electrode Function

Cleared on Jan 27, 2003 as substantially equivalent to K964190 (Biotronik, Inc., 1997) after a 192-day review. Its family tree reaches back 2 generations to 1988. 4 later devices descend from it.

Decided
Jan 27, 2003
Review
192 days
Class
Class II
Product code
DTA
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K883930 (1988). 3 ancestors in all. 4 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1989: 1 other ancestor2004: 1 descendant cleared2009: 1 descendant cleared2010: 1 descendant cleared2017: 1 descendant clearedK883930 · Seamed Model 3300 Dual Chamber Pacing System Analy · Seamed Corp. · 1988K964190 · Era 300 Dual Chamber Pacing System Analyzer · Biotronik, Inc. · 19971990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 1 descendant K964190 · Era 300 Dual Chamber Pacing System Analyzer · Biotronik, Inc. · 1997K883930 · Seamed Model 3300 Dual Chamber Pacing System Analy · Seamed Corp. · 19880
  1. Root · 2 generations backK883930 Seamed Model 3300 Dual Chamber Pacing System AnalySeamed Corp. · 1988
  2. 1 generation backK964190 Era 300 Dual Chamber Pacing System AnalyzerBiotronik, Inc. · 1997
  3. This deviceK022360 Era 3000; PA-2 IS-1 Adapter; EK-4-N Pacemaker Test Cable; Era 3000…Biotronik, Inc. · 2003
  4. Descendant · cites it directly · 1 of its ownK083674 PK-141 Patient CableBiotronik, Inc. · 2009
  5. Descendant · 2 generations on · 0 of its ownK170815 PSA CableBoston Scientific Corporation · 2017
  6. Descendant · cites it directly · 0 of its ownK101982 Merlin Psa Patient Cable EX 3150, Cable Adapter EX3170, M Adapter…St Jude Medical, Crmd · 2010
  7. Descendant · cites it directly · 0 of its ownK042708 Era 3000 Pacing System AnalyzerBiotronik, Inc. · 2004

Most influential descendants

Showing 4 of 4 · See all
  • K083674PK-141 Patient CableBiotronik, Inc. · 2009 · cites it directly1descendant
  • K170815PSA CableBoston Scientific Corporation · 2017 · 2 generations on0descendants
  • K101982Merlin Psa Patient Cable EX 3150, Cable Adapter EX3170, M Adapter EX3180St Jude Medical, Crmd · 2010 · cites it directly0descendants
  • K042708Era 3000 Pacing System AnalyzerBiotronik, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K883930Seamed Model 3300 Dual Chamber Pacing System AnalySeamed Corp.1988—
−1K964190Era 300 Dual Chamber Pacing System AnalyzerBiotronik, Inc.1997—
0 (this device)K022360Era 3000; PA-2 IS-1 Adapter; EK-4-N Pacemaker Test Cable; Era 3000 Charger…Biotronik, Inc.2003—
+1K083674PK-141 Patient CableBiotronik, Inc.2009—
+2K170815PSA CableBoston Scientific Corporation2017—
+1K101982Merlin Psa Patient Cable EX 3150, Cable Adapter EX3170, M Adapter EX3180St Jude Medical, Crmd2010—
+1K042708Era 3000 Pacing System AnalyzerBiotronik, Inc.2004—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200910
201010
201710
FIG. 1 — Lineage of K022360, 1988–2017Source: 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), 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 DTA? 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
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K964190Era 300 Dual Chamber Pacing System Analyzer
Summary page 1
…stem Analyzer cleared through 5101kl notification as a predicate device for the ERA 3000 Pacing System Analyzer: BIOTRONIKs ERA 300 Pacing System Analyzer l#K964190. cleared 07-10-971 Indications for Use: The ERA 3000 is intended for use during invasive pacemaker procedures in the following ac…
Biotronik, Inc.1997—

Also cleared against K964190: 4 other devices →

What descends from it? (4)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K083674PK-141 Patient CableBiotronik, Inc.20091
K101982Merlin Psa Patient Cable EX 3150, Cable Adapter EX3170, M Adapter EX3180St Jude Medical, Crmd20100
K042708Era 3000 Pacing System AnalyzerBiotronik, Inc.20040

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?

  • The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 8.7 years on median.
  • None of the 3 ancestors has a recall.
  • Of its descendants, K083674 (Biotronik, Inc., 2009) has gone furthest, with 1 descendant of its own.
  • 4 other devices also cite its predicate K964190.

How does its category compare?

All DTA devices

DTA Tester, Pacemaker Electrode Function: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DTA

1in 2017

2007: 12010: 12017: 1
2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DTA

Too few DTA 510(k)s in any year since 2007 to give a median.

Recalls per year · DTA

No recall names DTA since 2007.

Adverse event reports per year · DTA

1in 2023

2010: 12013: 22015: 12023: 1
2007high 2 (2013) · low 0 (2007)2025

MAUDE reports naming product code DTA, 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
20071—00
20080—00
20090—00
20101—01
20110—00
20120—00
20130—02
20140—00
20150—01
20160—00
20171—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—01
20240—00
20250—00
20260—0—

What is it indicated for?

The ERA 3000 is intended for use during invasive pacemaker procedures in the following activities:

Temporary External Pacing

Provides temporary stimulation under DDD, DDI, DOO, WI, VDD, VOO, MI, AOO, or OD0 modalities during implantable pacemaker procedures or physician evaluations.

Lead Threshold Determination

Determines in situ lead characteristics of impedance, capture threshold, P/R wave amplitude and P/R wave slew rate. Determines the in vivo retrograde conduction time.

Pacemaker Function Test

Tests and analyzes the in vitro operation of external or implantable pulse generators. Determines the following parameters: pulse amplitude and width, AN delay, and rate/interval.

Indications for use as stated in the FDA summary.

Also cleared against K964190

4 other devices cite the same predicate.

  • K123916Psa SeriesOsypka Medical, Inc. · 2013
  • K073230Models Era 300 and 3105 Pacing System AnalyzersBiotronik, Inc. · 2007
  • K050884Adapter CableRemington Medical, Inc. · 20051 recall
  • K033613Modification to Era 300 Dual Chamber Pacing System AnalyzerBiotronik, Inc. · 2003

More from Biotronik, Inc.

1,088 FDA decisions under this applicant name. See the company

  • P980023/S153Ilivia Neo 7 VRT DX, Intica Neo 7 VRT DX, Intica Neo 5 VRT DX, Acticor Sky VR-T, Rivacor Sky VR-T, Rivacor…Biotronik, Inc. · 2026
  • P950037/S299Edora 8 DR-T, Evity 8 DR-T, Enitra 8 DR-T, Enticos 8 DR-T, Evity 6 DR-T, Enitra 6 DR-T, Edora 8 DR, Enitra 6…Biotronik, Inc. · 2026
  • P050023/S216Ilivia 7 VRT DX, Intica 7 VRT DX, Intica 5 VRT DX, Ilivia 7 VRT, Intica 7 VRT, Intica 5 VRT, Inlexa 7 VRT…Biotronik, Inc. · 2026
  • P000009/S135Ilivia Neo 7 DRT, Intica Neo 7 DRT, Intica Neo 5 DRT, Acticor Sky DR-T, Rivacor Sky DR-T, Rivacor Rise DR-T…Biotronik, Inc. · 2026
  • P070008/S184Sentus ProMRI OTW QP S-75, Sentus ProMRI OTW QP S-85, Sentus ProMRI OTW QP S-95, Sentus ProMRI OTW QP L-75…Biotronik, Inc. · 2026

Recent decisions in DTA

The DTA category page

  • K163008CareLink SmartSync Device Manager - Pacing System AnalyzerMedtronic, Inc. · 2017
  • K101982Merlin Psa Patient Cable EX 3150, Cable Adapter EX3170, M Adapter EX3180St Jude Medical, Crmd · 2010
  • K073230Models Era 300 and 3105 Pacing System AnalyzersBiotronik, Inc. · 2007
  • K050884Adapter CableRemington Medical, Inc. · 20051 recall
  • K033613Modification to Era 300 Dual Chamber Pacing System AnalyzerBiotronik, Inc. · 2003

https://510kreport.com/device/K022360 · printed Nov 6, 2026

Cite this page

510(k) Report. “K022360: Era 3000; PA-2 IS-1 Adapter; EK-4-N Pacemaker Test Cable; Era 3000 Charger; Era 3000 Battery (Type 2); NK-11 Power Supp..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022360

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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