510(k) · Cleared
ClearedSolo Picc/Midline Catheter Kit Models 71924, 71908
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Douglas Medical Products Corp. · LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Cleared on Jun 18, 1996 as substantially equivalent to K932211 (Pharmacia Deltec, Inc., 1994) after an 88-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Jun 18, 1996
- Review
- 88 days
- Class
- Class II
- Product code
- LJS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K932211 (1994). No later device cites it as a predicate yet.
- Root · 1 generation backK932211 Procedural Tray for Peripherally Inserted VenousPharmacia Deltec, Inc. · 1994
- This deviceK961155 Solo Picc/Midline Catheter Kit Models 71924, 71908Douglas Medical Products Corp. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K932211 | Procedural Tray for Peripherally Inserted Venous | Pharmacia Deltec, Inc. | 1994 | — |
| 0 (this device) | K961155 | Solo Picc/Midline Catheter Kit Models 71924, 71908 | Douglas Medical Products Corp. | 1996 | — |
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K932211 | Procedural Tray for Peripherally Inserted VenousSummary page 1…ts are the same or the equivalent of the predicate devices named in this submission. The named predicate devices in this submission were the Clinicathtm Procedural Tray (K932211) marketed by SIMS Deltec, Inc. and the Per-Q-Cath Tray (K83145) marketed by Gesco Intl. , inc. The SoloPak Peripheral Intravenou… | 1994 |
| Kept off the family tree | K083145 | FDA’s K083145 is Asahi Guide Wire Extension, Model AG149000 Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2009 |
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?
- Its one ancestor has no recall.
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 SoloPak Peripheral Intravenous Catheter Insertion Kits are intended to be used for the placement of a peripheral catheter. The SoloPak Peripheral Intravenous Catheter Insertion Kits include a single lumen catheter, introducer, and the necessary accessories to perform the placement.
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/K961155 · printed Nov 4, 2026
Cite this page
510(k) Report. “K961155: Solo Picc/Midline Catheter Kit Models 71924, 71908.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961155
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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