510(k) · Cleared
Recalled · Class II · 2014Safe Connect Surgical Cable (S-101-97/S-201-97/FL-601-97)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Remington Medical, Inc. · DSA Cable, Transducer And Electrode, Patient, (Including Connector)
Cleared on Jul 23, 1997 after a 56-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- Jul 23, 1997
- Review
- 56 days
- Class
- Class II
- Product code
- DSA
- Recalls
- 2
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK971968 Safe Connect Surgical Cable (S-101-97/S-201-97/FL-601-97)Remington Medical, Inc. · 1997
- Descendant · cites it directly · 1 of its ownK093858 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 ownK152947 Disposable Temporary Pacing CableTiger Medical Products · 2016
- Descendant · 2 generations on · 0 of its ownK101982 Merlin Psa Patient Cable EX 3150, Cable Adapter EX3170, M Adapter…St Jude Medical, Crmd · 2010
Most influential descendants
Showing 3 of 3 · See all- K093858Psa Cable, Models 4160 and 4161 and Psa Cable Adapter, Model 4053ASt. Jude Medical, Cardiac Rhythm Management Divisi · 2010 · cites it directly1descendant
- K152947Disposable Temporary Pacing CableTiger Medical Products · 2016 · cites it directly0descendants
- K101982Merlin Psa Patient Cable EX 3150, Cable Adapter EX3170, M Adapter EX3180St Jude Medical, Crmd · 2010 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K971968 | Safe Connect Surgical Cable (S-101-97/S-201-97/FL-601-97) | Remington Medical, Inc. | 1997 | — |
| +1 | K093858 | Psa Cable, Models 4160 and 4161 and Psa Cable Adapter, Model 4053A | St. Jude Medical, Cardiac Rhythm Management Divisi | 2010 | — |
| +1 | K152947 | Disposable Temporary Pacing Cable | Tiger Medical Products | 2016 | — |
| +2 | K101982 | Merlin Psa Patient Cable EX 3150, Cable Adapter EX3170, M Adapter EX3180 | St Jude Medical, Crmd | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
| 2016 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DSA? 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 5, 2014 | Class II | Z-1441-2014 | Labeling Change Control | Remington Medical discovered an error on the FL-601-97 IFU; part number IFU-RM-0154. Specifically, the polarity for the black chuck in the picture is wrong. It shows (+), but should show (-). |
| May 19, 2010 | Not classified | Z-2223-2010 | Process design | The Safe Connect component may separate from the cable, causing the cable to become unplugged from the EPG. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K093858 (St. Jude Medical, Cardiac Rhythm Management Divisi, 2010) has gone furthest, with 1 descendant 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.
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 Remington Medical Disposable Surgical Extension Cable is an electrical extension cable used to transmit signal from, or power or excitation signal to patient-connected electrodes. The cable is bipolar, providing alligator clips at the end of the cable that will be attached to the patient's lead, and a safety plug at the other end that allows electrical connection to the external pacemaker or testing device (i.e. analyzer). The alligator clips are…
Read the full statement (129 words)
The Remington Medical Disposable Surgical Extension Cable is an electrical extension cable used to transmit signal from, or power or excitation signal to patient-connected electrodes. The cable is bipolar, providing alligator clips at the end of the cable that will be attached to the patient's lead, and a safety plug at the other end that allows electrical connection to the external pacemaker or testing device (i.e. analyzer). The alligator clips are color coded and imprinted with the polarity: The red clips are positive (+) and the black clips are negative (-).
The cable is designed to carry a maximum electrical load of 300 volts, and will be compatible with most external pacemakers, pace analyzers, and patient pacing leads currently on the market.
The cable is a sterile, disposable device.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K971968 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971968: Safe Connect Surgical Cable (S-101-97/S-201-97/FL-601-97).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971968
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