510(k) · Cleared
ClearedPSA Cable
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corporation · DTC Analyzer, Pacemaker Generator Function
Cleared on Jul 6, 2017 as substantially equivalent to K083674 (Biotronik, Inc., 2009) after a 111-day review. Its family tree reaches back 4 generations to 1988.
- Decided
- Jul 6, 2017
- Review
- 111 days
- Class
- Class II
- Product code
- DTC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K883930 (1988). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK883930 Seamed Model 3300 Dual Chamber Pacing System AnalySeamed Corp. · 1988
- 3 generations backK964190 Era 300 Dual Chamber Pacing System AnalyzerBiotronik, Inc. · 1997
- 2 generations backK022360 Era 3000; PA-2 IS-1 Adapter; EK-4-N Pacemaker Test Cable; Era 3000…Biotronik, Inc. · 2003
- 1 generation backK083674 PK-141 Patient CableBiotronik, Inc. · 2009
- This deviceK170815 PSA CableBoston Scientific Corporation · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K883930 | Seamed Model 3300 Dual Chamber Pacing System Analy | Seamed Corp. | 1988 | — |
| −3 | K964190 | Era 300 Dual Chamber Pacing System Analyzer | Biotronik, Inc. | 1997 | — |
| −2 | K022360 | Era 3000; PA-2 IS-1 Adapter; EK-4-N Pacemaker Test Cable; Era 3000 Charger… | Biotronik, Inc. | 2003 | — |
| −1 | K083674 | PK-141 Patient Cable | Biotronik, Inc. | 2009 | — |
| 0 (this device) | K170815 | PSA Cable | Boston Scientific Corporation | 2017 | — |
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 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 |
|---|---|---|---|
| * | K083674 | PK-141 Patient CableSummary page 4…, Cardiovascular Classification Regulation: 21 CFR 870.3630 3. Predicate Device Trade Name: PK-141 Patient Cable (PSA Cable) Manufacturer: Biotronik Clearance Number: K083674, April 1 2009 Common Name: PSA Cable Product Code: DTC Device Class and Panel: Class Il, Cardiovascular Classification Regulati… | 2009 |
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 29 years and passes through 3 companies; a new generation was cleared every 8.3 years on median.
- None of the 5 ancestors has a recall.
How does its category compare?
All DTC devicesDTC Analyzer, Pacemaker Generator Function: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 PSA cable is an accessory indicated for use with external PSA equipment distributed by Boston Scientific and is used for the transmission of sensing signals and pacing pulses for evaluation of lead placement characteristics during implant of pacemakers and defibrillators and for the support of other pacemaker functionality
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/K170815 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170815: PSA Cable.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170815
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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