510(k) · Cleared
ClearedPK-141 Patient Cable
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biotronik, Inc. · DTC Analyzer, Pacemaker Generator Function
Cleared on Apr 1, 2009 as substantially equivalent to K022360 (Biotronik, Inc., 2003) after a 111-day review. Its family tree reaches back 3 generations to 1988. 1 later device descends from it.
- Decided
- Apr 1, 2009
- Review
- 111 days
- Class
- Class II
- Product code
- DTC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K883930 (1988). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- 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 deviceK083674 PK-141 Patient CableBiotronik, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK170815 PSA CableBoston Scientific Corporation · 2017
Most influential descendants
Showing 1 of 1 · See all- K170815PSA CableBoston Scientific Corporation · 2017 · cites it directly0descendants
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) | K083674 | PK-141 Patient Cable | Biotronik, Inc. | 2009 | — |
| +1 | K170815 | PSA Cable | Boston Scientific Corporation | 2017 | — |
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 |
|---|---|---|
| 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 DTC? 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 |
|---|---|---|---|
| * | K022360 | Era 3000; PA-2 IS-1 Adapter; EK-4-N Pacemaker Test Cable; Era 3000 Charger; Era 3000…Summary page 1…ame: PK-141 Common Name: Programmer, Pacemaker (Accessories) Classification: Class Il (21 CFR 870.3700) Classification Name: Cabling Product Code: KRG §10(k) Number: K022360 Date Prepared: December 10, 2008 General Description: The PK-141 patient cable is compatible with the following BIOTRONIK extern… | 2003 |
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 |
|---|---|---|---|
| K170815 | PSA Cable | 2017 | 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 21 years and passes through 2 companies; a new generation was cleared every 6.2 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K170815 (Boston Scientific Corporation, 2017) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K022360.
How does its category compare?
All DTC devicesDTC Analyzer, Pacemaker Generator Function: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · DTC
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · DTC
Too few DTC 510(k)s in any year since 2007 to give a median.
Recalls per year · DTC
No recall names DTC since 2007.
Adverse event reports per year · DTC
1,159in 2025
MAUDE reports naming product code DTC, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 34 |
| 2018 | 0 | — | 0 | 22 |
| 2019 | 0 | — | 0 | 138 |
| 2020 | 0 | — | 0 | 189 |
| 2021 | 0 | — | 0 | 636 |
| 2022 | 0 | — | 0 | 218 |
| 2023 | 0 | — | 0 | 215 |
| 2024 | 0 | — | 0 | 1,076 |
| 2025 | 0 | — | 0 | 1,159 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The PK-141 patient cable is an accessory indicated for use with external equipment from BIOTRONIK and is used for the transmission of sensing signals and pacing pulses for diagnostics and therapy in the context of intracardiac examinations including the following activities: Temporary External Pacing Provides temporary stimulation during implantable pacemaker procedures or physician evaluations. Lead Threshold Determination Determines in situ lead…
Read the full statement (108 words)
The PK-141 patient cable is an accessory indicated for use with external equipment from BIOTRONIK and is used for the transmission of sensing signals and pacing pulses for diagnostics and therapy in the context of intracardiac examinations including the following activities:
Temporary External Pacing
Provides temporary stimulation 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 arid width, 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/K083674 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083674: PK-141 Patient Cable.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083674
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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