510(k) · Cleared
Recalled · 2004Clampless Valved Catheter-Picc (CVC-Picc)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bmw Medical, Inc. · LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Cleared on Oct 18, 1996 after a 70-day review. The FDA summary names its predicate without a number. 1 later device descends from it. It has been recalled 4 times.
- Decided
- Oct 18, 1996
- Review
- 70 days
- Class
- Class II
- Product code
- LJS
- Recalls
- 4
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK963097 Clampless Valved Catheter-Picc (CVC-Picc)Bmw Medical, Inc. · 1996
- Descendant · cites it directly · 0 of its ownK981368 Pasv Dual Lumen Peripherally Inserted Central Catheter (Picc) Model…Catheter Innovations, Inc. · 1998
Most influential descendants
Showing 1 of 1 · See all- K981368Pasv Dual Lumen Peripherally Inserted Central Catheter (Picc) Model Number Pic-NumerousCatheter Innovations, Inc. · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K963097 | Clampless Valved Catheter-Picc (CVC-Picc) | Bmw Medical, Inc. | 1996 | — |
| +1 | K981368 | Pasv Dual Lumen Peripherally Inserted Central Catheter (Picc) Model Number… | Catheter Innovations, Inc. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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 |
|---|---|---|---|
| * | — | Groshong Long-term PICC Named without a submission number | |
| * | — | HDC V-Cath® PICC Named without a submission number |
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 |
|---|---|---|---|
| K981368 | Pasv Dual Lumen Peripherally Inserted Central Catheter (Picc) Model Number Pic-Numerous | 1998 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 5, 2004 | Not classified | Z-1051-05 | Other | Lumens may have incorrect lumen size marked on them. |
| Mar 5, 2004 | Not classified | Z-1049-05 | Other | Lumens may have incorrect lumen size marked on them. |
| Mar 5, 2004 | Not classified | Z-1050-05 | Other | Lumens may have incorrect lumen size marked on them. |
| Mar 5, 2004 | Not classified | Z-1052-05 | Other | Lumens may have incorrect lumen size marked on them. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K981368 (Catheter Innovations, Inc., 1998) has gone furthest, with 0 descendants of its own.
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?
BMW’s CVC-PICC is designed to establish peripheral access to the central venous system for administration of fluids including, but not limited to, hydration agents, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. It is also indicated for blood specimen withdrawal.
This product is effective for venous access in adults, children, and infants who require intravenous therapy.
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/K963097 · printed Nov 5, 2026
Cite this page
510(k) Report. “K963097: Clampless Valved Catheter-Picc (CVC-Picc).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K963097
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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