510(k) · Cleared
ClearedMerlin Psa Patient Cable EX 3150, Cable Adapter EX3170, M Adapter EX3180
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
St Jude Medical, Crmd · DTA Tester, Pacemaker Electrode Function
Cleared on Dec 21, 2010 as substantially equivalent to K022360 (Biotronik, Inc., 2003) and 1 other predicate after a 160-day review. Its family tree reaches back 3 generations to 1988. 1 of the 10 devices in its family, counting itself, has a Class I recall.
- Decided
- Dec 21, 2010
- Review
- 160 days
- Class
- Class II
- Product code
- DTA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K883930 (1988). 9 ancestors in all. No later device cites it as a predicate yet. 1 of the 10 devices in this family, counting this one, has a Class I recall.
- 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 deviceK101982 Merlin Psa Patient Cable EX 3150, Cable Adapter EX3170, M Adapter…St Jude Medical, Crmd · 2010
Class I recalls in this family
- P950022 TVL (TM) Lead System2 generations back · 1996
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) | K101982 | Merlin Psa Patient Cable EX 3150, Cable Adapter EX3170, M Adapter EX3180 | St Jude Medical, Crmd | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 1 | 1 |
| 1997 | 1 | 0 |
| 2004 | 1 | 0 |
| 2010 | 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.
1 device in this family has a Class I recall. 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? (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 |
|---|---|---|---|
| * | K022360 | Era 3000; PA-2 IS-1 Adapter; EK-4-N Pacemaker Test Cable; Era 3000 Charger; Era 3000…Summary page 1…: Class 11, 21CFR870.3720 Legally marketed device to which your firm is claiming equivalence: Biotronik Patient Cable PK 67-L and the PA-4 Adapter (K022360 cleared on January 27, 2003) and St. Jude Medical PSA Cable Adapter M… | 2003 |
| * | K093858 | Psa Cable, Models 4160 and 4161 and Psa Cable Adapter, Model 4053ASummary page 1…PA-4 Adapter (K022360 cleared on January 27, 2003) and St. Jude Medical PSA Cable Adapter Model Number 4053A (K093858 cleared on April 2, 2010) INDICATIONS FOR USEIINTENDED USE The Merlin PSA Patient Cable EX3 150 i… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- P950022TVL (TM) Lead SystemAbbott Medical · 1996 · 2 generations back · ◆ in the 1996 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 7.9 years on median.
- 4 of the 9 ancestors have a recall of any class; 1 has a Class I recall.
- 2 other devices also cite its predicate K022360.
How does its category compare?
All DTA devicesDTA Tester, Pacemaker Electrode Function: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
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 Merlin PSA Patient Cable EX3 150 is a three-channel resterilizable patient cable intended to connect the Merlin PSA to as many as three IS-I leads or to SJ4 leads. The Merlin PSA Patient Cable Adapter EX3 170 is a three-channel adapter intended to connect the Merlin PSA to as many as three disposable patient cables. The EX3 170 Cable Adapter can connect to the Models 4051/4051IA disposable patient cables for IS-i leads or to the Model 4161 disposable…
Read the full statement (153 words)
The Merlin PSA Patient Cable EX3 150 is a three-channel resterilizable patient cable intended to connect the Merlin PSA to as many as three IS-I leads or to SJ4 leads.
The Merlin PSA Patient Cable Adapter EX3 170 is a three-channel adapter intended to connect the Merlin PSA to as many as three disposable patient cables. The EX3 170 Cable Adapter can connect to the Models 4051/4051IA disposable patient cables for IS-i leads or to the Model 4161 disposable patient cable for SJ4 leads. The opposite ends of the disposable patient cables connect to implantable pacing leads.
The Merlin PSA "M" Adapter Model EX3 180 is intended to connect the Merlin PSA to the two-channel Medtronic Model 2292 re-sterilizable patient cable. The opposite end of the Medtronic Model 2292 cable connects to implantable pacing leads.
Following use, the patient cables must either be disposed or re-sterilized, depending on the requirements of the cable.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101982 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101982: Merlin Psa Patient Cable EX 3150, Cable Adapter EX3170, M Adapter EX3180.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101982
Report an extraction error
Are you the manufacturer?
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