510(k) · Cleared
ClearedPsa Cable, Models 4160 and 4161 and Psa Cable Adapter, Model 4053A
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
St. Jude Medical, Cardiac Rhythm Management Divisi · DSA Cable, Transducer And Electrode, Patient, (Including Connector)
Cleared on Apr 2, 2010 as substantially equivalent to P910023 (Abbott Medical, 1993) and 3 other predicates after a 107-day review. Its family tree reaches back 1 generation to 1993. 1 of the 6 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Apr 2, 2010
- Review
- 107 days
- Class
- Class II
- Product code
- DSA
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to P910023 (1993). 4 ancestors in all. 1 later device descends from it, 1 citing it directly. 1 of the 6 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backP910023 Cadence (R) Tiered Therapy Defibrillation SystemAbbott Medical · 1993 · Recalled
- This deviceK093858 Psa Cable, Models 4160 and 4161 and Psa Cable Adapter, Model 4053ASt. Jude Medical, Cardiac Rhythm Management Divisi · 2010
- Descendant · cites it directly · 0 of its ownK101982 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 Systemdirect predicate · 1996
Most influential descendants
Showing 1 of 1 · See all- K101982Merlin Psa Patient Cable EX 3150, Cable Adapter EX3170, M Adapter EX3180St Jude Medical, Crmd · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | P910023 | Cadence (R) Tiered Therapy Defibrillation System | Abbott Medical | 1993 | 40 |
| 0 (this device) | K093858 | Psa Cable, Models 4160 and 4161 and Psa Cable Adapter, Model 4053A | St. Jude Medical, Cardiac Rhythm Management Divisi | 2010 | — |
| +1 | 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 |
|---|---|---|
| 1996 | 1 | 1 |
| 1997 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
Top candidate predicates for a new DSA device
- #1 K252827 IBP cable Becton Dickinson (2606488); IBP…score 11.3 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | P910023 | Cadence (R) Tiered Therapy Defibrillation SystemSummary page 1…_ _ _ _ _ _ _ _ _ _ _ _ _ _ P910023 /SI154, 4160 4160 P030054/S67, January 13, 2009… | 1993 |
| * | P030054 | ST Jude Medical Epic HF SystemSummary page 1…P910023 /SI154, 4160 4160 P030054/S67, January 13, 2009 _____ ____ _____… | 2004 |
| * | P950022 | TVL (TM) Lead SystemSummary page 1…P030054/S67, January 13, 2009 _____ ____ _____ ____ P950022 /S42 P910023 SI… | 1996 |
| * | K971968 | Safe Connect Surgical Cable (S-101-97/S-201-97/FL-601-97)Summary page 1…Remington Medical 4053A cable K97 1968 July 23, 1997 adapter ______… | 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 |
|---|---|---|---|
| K101982 | Merlin Psa Patient Cable EX 3150, Cable Adapter EX3170, M Adapter EX3180 | 2010 | 0 |
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 · Direct predicate · ◆ in the 1996 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- 4 of the 4 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K101982 (St Jude Medical, Crmd, 2010) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DSA devicesDSA Cable, Transducer And Electrode, Patient, (Including Connector): FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · DSA
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DSA
105in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DSA
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DSA
67in 2025
MAUDE reports naming product code DSA, 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 | 2 | — | 0 | 4 |
| 2008 | 6 | 59 | 0 | 11 |
| 2009 | 0 | — | 0 | 5 |
| 2010 | 4 | 55 | 2 | 1 |
| 2011 | 1 | — | 0 | 4 |
| 2012 | 1 | — | 0 | 8 |
| 2013 | 1 | — | 0 | 23 |
| 2014 | 1 | — | 0 | 67 |
| 2015 | 0 | — | 0 | 34 |
| 2016 | 2 | — | 0 | 28 |
| 2017 | 5 | 140 | 0 | 5 |
| 2018 | 3 | 84 | 0 | 16 |
| 2019 | 4 | 140 | 0 | 11 |
| 2020 | 6 | 177 | 0 | 31 |
| 2021 | 4 | 164 | 0 | 7 |
| 2022 | 2 | — | 1 | 49 |
| 2023 | 3 | 240 | 0 | 29 |
| 2024 | 3 | 102 | 0 | 40 |
| 2025 | 4 | 105 | 0 | 67 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Model 4160 PSA disposable threshold cable is intended to connect IS- I or SJ4 leads to the Biotronik PK-67S PSA patient cable adapter and, in turn, to the SJM Model 3150 PSA or Biotronik Model ERA 300B PSA (Pacing System Analyzer) located outside the sterile field. The Model 4161 PSA disposable threshold cable is intended to connect IS- I or SJ4 leads to St. Jude Medical PSA patient cable adapter Models 4053 and 4053A and, in turn, to a testing…
Read the full statement (144 words)
The Model 4160 PSA disposable threshold cable is intended to connect IS- I or SJ4 leads to the Biotronik PK-67S PSA patient cable adapter and, in turn, to the SJM Model 3150 PSA or Biotronik Model ERA 300B PSA (Pacing System Analyzer) located outside the sterile field.
The Model 4161 PSA disposable threshold cable is intended to connect IS- I or SJ4 leads to St. Jude Medical PSA patient cable adapter Models 4053 and 4053A and, in turn, to a testing device such as a PSA (Pacing System Analyzer) located outside the sterile field.
The Model 4053A non-disposable PSA cable adapter is intended to be used with the St. Jude Medical Model 4051 and 405 1 A cables to connect a cardiac pacing lead to the SJM Model 3150 PSA or Biotronik model ERA 300B PSA (Pacing System Analyzer) located outside the sterile field.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093858 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093858: Psa Cable, Models 4160 and 4161 and Psa Cable Adapter, Model 4053A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093858
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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