510(k) · Cleared
ClearedEra 3000 Pacing System Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biotronik, Inc. · DTE Pulse-Generator, Pacemaker, External
Cleared on Oct 20, 2004 as substantially equivalent to K022360 (Biotronik, Inc., 2003) after a 20-day review. Its family tree reaches back 3 generations to 1988.
- Decided
- Oct 20, 2004
- Review
- 20 days
- Class
- Class II
- Product code
- DTE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K883930 (1988). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK883930 Seamed Model 3300 Dual Chamber Pacing System AnalySeamed Corp. · 1988
- 2 generations backK964190 Era 300 Dual Chamber Pacing System AnalyzerBiotronik, Inc. · 1997
- 1 generation backK022360 Era 3000; PA-2 IS-1 Adapter; EK-4-N Pacemaker Test Cable; Era 3000…Biotronik, Inc. · 2003
- This deviceK042708 Era 3000 Pacing System AnalyzerBiotronik, Inc. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K883930 | Seamed Model 3300 Dual Chamber Pacing System Analy | Seamed Corp. | 1988 | — |
| −2 | K964190 | Era 300 Dual Chamber Pacing System Analyzer | Biotronik, Inc. | 1997 | — |
| −1 | K022360 | Era 3000; PA-2 IS-1 Adapter; EK-4-N Pacemaker Test Cable; Era 3000 Charger… | Biotronik, Inc. | 2003 | — |
| 0 (this device) | K042708 | Era 3000 Pacing System Analyzer | Biotronik, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 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 DTE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DTE device
- #1 K232721 Lifetech Cardio Temporary Pacemakerscore 7.2 · 3 generations · no Class I recall
- #2 Held for the reportin 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 |
|---|---|---|---|
| * | K022360 | Era 3000; PA-2 IS-1 Adapter; EK-4-N Pacemaker Test Cable; Era 3000 Charger; Era 3000…Summary page 1…System Analyzer cleared through 510(k) notification as a predicate device for the ERA 3000 Pacing System Analyzer: BIOTRONIK's ERA 3000 Pacing System Analyzer (#K022360, cleared 01-27-03) Indications for Use: The ERA 3000 is intended for use during invasive pacemaker pmocedures in thie following… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
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 16 years and passes through 2 companies; a new generation was cleared every 5.5 years on median.
- None of the 4 ancestors has a recall.
- 2 other devices also cite its predicate K022360.
How does its category compare?
All DTE devicesDTE Pulse-Generator, Pacemaker, External: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DTE
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DTE
Too few DTE 510(k)s in any year since 2007 to give a median.
Recalls per year · DTE
2in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DTE
636in 2025
MAUDE reports naming product code DTE, 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 | 17 |
| 2008 | 0 | — | 0 | 22 |
| 2009 | 0 | — | 0 | 39 |
| 2010 | 0 | — | 2 | 335 |
| 2011 | 0 | — | 0 | 1,865 |
| 2012 | 0 | — | 0 | 1,786 |
| 2013 | 2 | — | 0 | 98 |
| 2014 | 0 | — | 0 | 67 |
| 2015 | 1 | — | 0 | 342 |
| 2016 | 2 | — | 0 | 496 |
| 2017 | 0 | — | 0 | 654 |
| 2018 | 2 | — | 0 | 956 |
| 2019 | 2 | — | 0 | 1,001 |
| 2020 | 1 | — | 0 | 1,092 |
| 2021 | 0 | — | 0 | 899 |
| 2022 | 0 | — | 0 | 833 |
| 2023 | 0 | — | 0 | 650 |
| 2024 | 1 | — | 0 | 620 |
| 2025 | 1 | — | 0 | 636 |
| 2026 | 0 | — | 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 ODD, DDI, DOO, VVI, VDD, VOO, AAI, or AOO 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…
Read the full statement (97 words)
The ERA 3000 is intended for use during invasive pacemaker procedures in the following activities:
* Temporary External Pacing
Provides temporary stimulation under ODD, DDI, DOO, VVI, VDD, VOO, AAI, or AOO 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, A/V delay, and rate/interval.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042708 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042708: Era 3000 Pacing System Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042708
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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