510(k) · Cleared
ClearedPeripherally Inserted Central
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
B.Braun Medical, Inc. · LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Cleared on Nov 24, 1997 as substantially equivalent to K861479 (Burron Medical Products, Inc., 1986) after a 178-day review. Its family tree reaches back 1 generation to 1986. 4 later devices descend from it.
- Decided
- Nov 24, 1997
- Review
- 178 days
- Class
- Class II
- Product code
- LJS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K861479 (1986). 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK861479 Cavafix, Central Venous Catheter KitBurron Medical Products, Inc. · 1986
- This deviceK971999 Peripherally Inserted CentralB.Braun Medical, Inc. · 1997
- Descendant · cites it directly · 3 of its ownK031689 Dual Lumen Extended Length Catheter (Delc)Chf Solutions, Inc. · 2003
- Descendant · 2 generations on · 2 of its ownK041791 5.2F Dual Lumen Extended Length Catheter (Delc)Chf Solutions, Inc. · 2004
- Descendant · 2 generations on · 1 of its ownK233515 Dual Lumen Extended Length Catheter (dELC), 6F, 12 cm (320101), Dual…Nuwellis, Inc. · 2023
- Descendant · 3 generations on · 0 of its ownK252226 Dual Lumen Extended Length Catheter (dELC), 6F, 12cm (320101); Dual…Nuwellis, Inc. · 2025
Most influential descendants
Showing 4 of 4 · See all- K031689Dual Lumen Extended Length Catheter (Delc)Chf Solutions, Inc. · 2003 · cites it directly3descendants
- K0417915.2F Dual Lumen Extended Length Catheter (Delc)Chf Solutions, Inc. · 2004 · 2 generations on2descendants
- K233515Dual Lumen Extended Length Catheter (dELC), 6F, 12 cm (320101), Dual Lumen Extended…Nuwellis, Inc. · 2023 · 2 generations on1descendant
- K252226Dual Lumen Extended Length Catheter (dELC), 6F, 12cm (320101); Dual Lumen Extended…Nuwellis, Inc. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K861479 | Cavafix, Central Venous Catheter Kit | Burron Medical Products, Inc. | 1986 | — |
| 0 (this device) | K971999 | Peripherally Inserted Central | B.Braun Medical, Inc. | 1997 | — |
| +1 | K031689 | Dual Lumen Extended Length Catheter (Delc) | Chf Solutions, Inc. | 2003 | — |
| +2 | K041791 | 5.2F Dual Lumen Extended Length Catheter (Delc) | Chf Solutions, Inc. | 2004 | — |
| +2 | K233515 | Dual Lumen Extended Length Catheter (dELC), 6F, 12 cm (320101), Dual Lumen… | Nuwellis, Inc. | 2023 | — |
| +3 | K252226 | Dual Lumen Extended Length Catheter (dELC), 6F, 12cm (320101); Dual Lumen… | Nuwellis, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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 LJS? 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 LJS device
- #1 K241910 Neonav ECG Tip Location Systemscore 18.0 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K861479 | Cavafix, Central Venous Catheter KitSummary page 1…tory Affairs Product Name: Midclavicular Catheter Trade Name: Cavafix Classification name: Cardiovascular Class Ii, 80FOZ 21 CFR 880.5200 SUBSTANTIAL EQUIVALENCE! TO: K861479 Cavafix B. Braun Medical inc. UNKNOWN SoloPICC SoloPak Device Description: In accordance with section 510(k) for the Federal Foo… | 1986 |
| * | — | SoloPICC Named without a submission number |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031689 | Dual Lumen Extended Length Catheter (Delc) | 2003 | 3 |
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?
How does its category compare?
All LJS devicesLJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LJS
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LJS
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LJS
5in 2023
Class I (3 since 2007) Class II/III not classified
Adverse event reports per year · LJS
4,372in 2025
MAUDE reports naming product code LJS, 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 | 14 | 92 | 0 | 392 |
| 2008 | 4 | 97 | 1 | 369 |
| 2009 | 16 | 70 | 1 | 379 |
| 2010 | 9 | 114 | 12 | 495 |
| 2011 | 6 | 55 | 4 | 696 |
| 2012 | 14 | 77 | 40 | 564 |
| 2013 | 14 | 31 | 0 | 680 |
| 2014 | 8 | 47 | 15 | 842 |
| 2015 | 7 | 71 | 2 | 1,306 |
| 2016 | 9 | 128 | 18 | 1,123 |
| 2017 | 7 | 101 | 9 | 2,100 |
| 2018 | 10 | 148 | 3 | 2,324 |
| 2019 | 0 | — | 0 | 2,052 |
| 2020 | 2 | — | 0 | 2,539 |
| 2021 | 3 | 284 | 1 | 3,084 |
| 2022 | 3 | 177 | 0 | 3,256 |
| 2023 | 4 | 47 | 5 (2) | 2,799 |
| 2024 | 1 | — | 0 | 4,243 |
| 2025 | 8 | 171 | 0 | 4,372 |
| 2026 | 2 | — | 8 (1) | — |
What is it indicated for?
The device is designed to be inserted into the peripheral vein for the infusion.
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/K971999 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971999: Peripherally Inserted Central.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971999
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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