510(k) · Cleared
ClearedSafpace System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
B.Braun Medical, Inc. · LDF Electrode, Pacemaker, Temporary
Cleared on Nov 18, 1997 as substantially equivalent to K803058 (American Edwards Laboratories, 1981) and 1 other predicate after a 693-day review. Its family tree reaches back 1 generation to 1981.
- Decided
- Nov 18, 1997
- Review
- 693 days
- Class
- Class II
- Product code
- LDF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K803058 (1981). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK803058 Swan-Ganz Flow-Directed Multipur. Cath.American Edwards Laboratories · 1981
- This deviceK955829 Safpace SystemB.Braun Medical, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K803058 | Swan-Ganz Flow-Directed Multipur. Cath. | American Edwards Laboratories | 1981 | — |
| 0 (this device) | K955829 | Safpace System | B.Braun Medical, Inc. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 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 LDF? 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 LDF device
- #1 K241334 Semi-Floating Temporary Pacing Electrode…score 12.1 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K803058 | Swan-Ganz Flow-Directed Multipur. Cath.Summary page 1…re. CLASSIFICATION NAME: Cardiovascular Class II ,74 LDF, Temporary Pacemaker Electrode 21 CFR 870.3680 SUBSTANTIAL EQUIVALENCE! TO: | flSIO(k) number Name Applicant K803058 Swan-Ganz Flow ‘ flpireqtedHC§Fheter American Edwards Laboratories VastoStim Vascor Medical | K822806/A Balloon Wedge formally;… | 1981 |
| * | K822806 | Balloon Wedge Pressure, AngiographicSummary page 1…SUBSTANTIAL EQUIVALENCE! TO: | flSIO(k) number Name Applicant K803058 Swan-Ganz Flow ‘ flpireqtedHC§Fheter American Edwards Laboratories VastoStim Vascor Medical | K822806/A Balloon Wedge formally; l Pressure, Nova Medical ( Angiographic and Specialties Pacing Catheters now a division of B. Braun Me… | 1982 |
| * | — | VastoStim Named without a submission number |
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?
- 1 of the 2 ancestors has a recall of any class.
How does its category compare?
All LDF devicesLDF Electrode, Pacemaker, Temporary: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LDF
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LDF
266in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LDF
1in 2018
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · LDF
139in 2025
MAUDE reports naming product code LDF, 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 | 25 |
| 2008 | 1 | — | 2 | 18 |
| 2009 | 0 | — | 2 | 44 |
| 2010 | 0 | — | 0 | 48 |
| 2011 | 0 | — | 1 | 35 |
| 2012 | 0 | — | 1 | 68 |
| 2013 | 0 | — | 0 | 74 |
| 2014 | 1 | — | 0 | 68 |
| 2015 | 2 | — | 0 | 81 |
| 2016 | 3 | 138 | 0 | 90 |
| 2017 | 1 | — | 0 | 79 |
| 2018 | 1 | — | 1 (1) | 91 |
| 2019 | 1 | — | 0 | 130 |
| 2020 | 0 | — | 0 | 83 |
| 2021 | 0 | — | 0 | 125 |
| 2022 | 0 | — | 0 | 117 |
| 2023 | 0 | — | 0 | 212 |
| 2024 | 1 | — | 0 | 190 |
| 2025 | 5 | 266 | 0 | 139 |
| 2026 | 1 | — | 1 (1) | — |
What is it indicated for?
The catheter is designed for accurate measurement of cardiac output, direct measurement of pulmonary artery blood temperature, pressure monitoring, and infusing solutions. The SafPace™ catheter may also be used for temporary ventricular pacing. The V-Pacing Wire is used for temporary ventricular pacing only when used with the SafPace™ catheter. The wire may also be used for intraventricular ECG monitoring.
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/K955829 · printed Nov 6, 2026
Cite this page
510(k) Report. “K955829: Safpace System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K955829
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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