510(k) · Cleared
ClearedEra 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. · DTE Pulse-Generator, Pacemaker, External
Cleared on Jul 10, 1997 as substantially equivalent to K883930 (Seamed Corp., 1988) and 1 other predicate after a 262-day review. Its family tree reaches back 1 generation to 1988. 9 later devices descend from it.
- Decided
- Jul 10, 1997
- Review
- 262 days
- Class
- Class II
- Product code
- DTE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K883930 (1988). 2 ancestors in all. 9 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK883930 Seamed Model 3300 Dual Chamber Pacing System AnalySeamed Corp. · 1988
- This deviceK964190 Era 300 Dual Chamber Pacing System AnalyzerBiotronik, Inc. · 1997
- Descendant · cites it directly · 4 of its ownK022360 Era 3000; PA-2 IS-1 Adapter; EK-4-N Pacemaker Test Cable; Era 3000…Biotronik, Inc. · 2003
- Descendant · 2 generations on · 1 of its ownK083674 PK-141 Patient CableBiotronik, Inc. · 2009
- Descendant · cites it directly · 1 of its ownK033613 Modification to Era 300 Dual Chamber Pacing System AnalyzerBiotronik, Inc. · 2003
- Descendant · 3 generations on · 0 of its ownK170815 PSA CableBoston Scientific Corporation · 2017
- Descendant · cites it directly · 0 of its ownK123916 Psa SeriesOsypka Medical, Inc. · 2013
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K022360Era 3000; PA-2 IS-1 Adapter; EK-4-N Pacemaker Test Cable; Era 3000 Charger; Era 3000…Biotronik, Inc. · 2003 · cites it directly4descendants
- K083674PK-141 Patient CableBiotronik, Inc. · 2009 · 2 generations on1descendant
- K033613Modification to Era 300 Dual Chamber Pacing System AnalyzerBiotronik, Inc. · 2003 · cites it directly1descendant
- K170815PSA CableBoston Scientific Corporation · 2017 · 3 generations on0descendants
- K123916Psa SeriesOsypka Medical, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K883930 | Seamed Model 3300 Dual Chamber Pacing System Analy | Seamed Corp. | 1988 | — |
| 0 (this device) | 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 | — |
| +2 | K083674 | PK-141 Patient Cable | Biotronik, Inc. | 2009 | — |
| +1 | K033613 | Modification to Era 300 Dual Chamber Pacing System Analyzer | Biotronik, Inc. | 2003 | — |
| +3 | K170815 | PSA Cable | Boston Scientific Corporation | 2017 | — |
| +1 | K123916 | Psa Series | Osypka Medical, Inc. | 2013 | — |
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 |
|---|---|---|
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 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? (2)
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 |
|---|---|---|---|
| * | K883930 | Seamed Model 3300 Dual Chamber Pacing System AnalySummary page 1…nerator. 3. Substantial Equivalence The ERA 300 is substantially equivalent to the FDA-cleared SeaMED Model 3300 Dual-Chamber Pacing System Analyzer, approved 8/19/86 (K883930), and the Medtronic Model 5311B A-V Pacing System Analyzer, approved (K884331). Data to support this statement are provided in th… | 1988 |
| * | K884331 | Medtronic Model 5311B a-V Pacing System AnalyzerSummary page 1…to the FDA-cleared SeaMED Model 3300 Dual-Chamber Pacing System Analyzer, approved 8/19/86 (K883930), and the Medtronic Model 5311B A-V Pacing System Analyzer, approved (K884331). Data to support this statement are provided in the premarket notification. 4. Intended Use The ERA 300 is intended for use in… | 1989 |
What descends from it? (9)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K022360 | Era 3000; PA-2 IS-1 Adapter; EK-4-N Pacemaker Test Cable; Era 3000 Charger; Era 3000… | 2003 | 4 |
| K033613 | Modification to Era 300 Dual Chamber Pacing System Analyzer | 2003 | 1 |
| K123916 | Psa Series | 2013 | 0 |
| K073230 | Models Era 300 and 3105 Pacing System Analyzers | 2007 | 0 |
| K050884 | Adapter Cable | 2005 | 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?
- None of the 2 ancestors has a recall.
- Of its descendants, K022360 (Biotronik, Inc., 2003) has gone furthest, with 4 descendants of its own.
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 300 is indicated for use during invasive pacing system procedures in the following activities: TEMPORARY EXTERNAL PACING To provide temporary stimulation under DDD, DDI, DOO, VVI, VDD, VOO, AAI or AOO modalities during implantable pacemaker procedures or physician evaluations. LEAD THRESHOLD DETERMINATION To determine in situ lead characteristics of impedance, capture threshold, P/R wave amplitude and P/R wave slew rate. To determine the in vivo…
Read the full statement (103 words)
The ERA 300 is indicated for use during invasive pacing system procedures in the following activities:
TEMPORARY EXTERNAL PACING
To provide temporary stimulation under DDD, DDI, DOO, VVI, VDD, VOO,
AAI or AOO modalities during implantable pacemaker procedures or
physician evaluations.
LEAD THRESHOLD DETERMINATION
To determine in situ lead characteristics of impedance, capture threshold, P/R
wave amplitude and P/R wave slew rate. To determine the in vivo retrograde
conduction time.
PACEMAKER FUNCTION TEST
To test and analyze the in vitro operation of external or implantable pulse
generators. To determine the following parameters: pulse amplitude and
width, sensitivity, refractory period, A/V delay, and rate/interval.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K964190 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964190: Era 300 Dual Chamber Pacing System Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964190
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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