510(k) · Cleared
ClearedModification to Era 300 Dual Chamber Pacing System Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biotronik, Inc. · DTA Tester, Pacemaker Electrode Function
Cleared on Dec 8, 2003 as substantially equivalent to K964190 (Biotronik, Inc., 1997) after a 21-day review. Its family tree reaches back 2 generations to 1988. 1 later device descends from it.
- Decided
- Dec 8, 2003
- Review
- 21 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. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK883930 Seamed Model 3300 Dual Chamber Pacing System AnalySeamed Corp. · 1988
- 1 generation backK964190 Era 300 Dual Chamber Pacing System AnalyzerBiotronik, Inc. · 1997
- This deviceK033613 Modification to Era 300 Dual Chamber Pacing System AnalyzerBiotronik, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK073230 Models Era 300 and 3105 Pacing System AnalyzersBiotronik, Inc. · 2007
Most influential descendants
Showing 1 of 1 · See all- K073230Models Era 300 and 3105 Pacing System AnalyzersBiotronik, Inc. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K883930 | Seamed Model 3300 Dual Chamber Pacing System Analy | Seamed Corp. | 1988 | — |
| −1 | K964190 | Era 300 Dual Chamber Pacing System Analyzer | Biotronik, Inc. | 1997 | — |
| 0 (this device) | K033613 | Modification to Era 300 Dual Chamber Pacing System Analyzer | Biotronik, Inc. | 2003 | — |
| +1 | K073230 | Models Era 300 and 3105 Pacing System Analyzers | Biotronik, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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 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
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 |
|---|---|---|---|
| * | K964190 | Era 300 Dual Chamber Pacing System AnalyzerSummary page 1…cing System Analyzer cleared through 510(k) notification as a predicate device for the ERA 300 Pacing System Analyzer: · BIOTRONIK's ERA 300 Pacing System Analyzer (#K964190, cleared 07-10-97) Indications for Use: The ERA 300 is intended for use during invasive pacemaker procedures in the following act… | 1997 |
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 |
|---|---|---|---|
| K073230 | Models Era 300 and 3105 Pacing System Analyzers | 2007 | 0 |
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, K073230 (Biotronik, Inc., 2007) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K964190.
How does its category compare?
All DTA devicesDTA Tester, Pacemaker Electrode Function: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DTA
1in 2017
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
MAUDE reports naming product code DTA, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ERA 300 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, 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 (100 words)
The ERA 300 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, 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, sensitivity, refractory period, A/V delay, and
rate/interval.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033613 · printed Nov 5, 2026
Cite this page
510(k) Report. “K033613: Modification to Era 300 Dual Chamber 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/K033613
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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