510(k) · Cleared
ClearedPasv Dual Lumen Peripherally Inserted Midline Catheter Model Number Midline-Numerous
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Catheter Innovations, Inc. · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on May 1, 1998 after a 15-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- May 1, 1998
- Review
- 15 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
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 FOZ? 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 FOZ device
- #1 K243403 BD Nexiva™ Closed IV Catheter Systemscore 14.8 · 8 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?
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.
How does its category compare?
All FOZ devicesFOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FOZ
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FOZ
91in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FOZ
4in 2023
Class I (5 since 2007) Class II/III not classified
Adverse event reports per year · FOZ
5,110in 2025
MAUDE reports naming product code FOZ, 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 | 6 | 159 | 16 | 374 |
| 2008 | 9 | 103 | 0 | 422 |
| 2009 | 9 | 30 | 23 | 508 |
| 2010 | 3 | 28 | 115 | 370 |
| 2011 | 6 | 132 | 0 | 786 |
| 2012 | 13 | 122 | 0 | 560 |
| 2013 | 4 | 104 | 2 | 640 |
| 2014 | 9 | 99 | 4 | 815 |
| 2015 | 10 | 107 | 0 | 729 |
| 2016 | 9 | 63 | 3 (1) | 925 |
| 2017 | 9 | 51 | 22 | 1,966 |
| 2018 | 1 | — | 4 | 3,305 |
| 2019 | 8 | 140 | 3 | 4,365 |
| 2020 | 10 | 191 | 3 | 3,797 |
| 2021 | 4 | 242 | 1 | 4,674 |
| 2022 | 8 | 183 | 4 (2) | 4,133 |
| 2023 | 9 | 129 | 4 (2) | 4,430 |
| 2024 | 6 | 190 | 0 | 4,772 |
| 2025 | 11 | 91 | 0 | 5,110 |
| 2026 | 7 | 203 | 2 | — |
What is it indicated for?
Catheter Innovations, Inc. PASV™ Dual Lumen Peripherally Inserted Midline Catheter is designed to establish peripheral access to the venous system for administration of fluids including, but not limited to, hydration agents, antibiotics, analgesics, 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. Warning: The PASV™ Dual…
Read the full statement (125 words)
Catheter Innovations, Inc. PASV™ Dual Lumen Peripherally Inserted Midline Catheter is designed to establish peripheral access to the venous system for administration of fluids including, but not limited to, hydration agents, antibiotics, analgesics, 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.
Warning: The PASV™ Dual Lumen Peripherally Inserted Midline Catheter is NOT indicated for infusion of the following:
• Hypertonic nutrition solutions with final glucose concentrations greater than 10%
• Continuously infused Vesicant Drugs
• Any medication contraindicated for infusion into the peripheral system
Catheter Innovations, Inc. PASV™ Dual Lumen Peripherally Inserted Midline Catheters have the same intended use as our Single Lumen Midline Catheters (K963215).
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981382 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981382: Pasv Dual Lumen Peripherally Inserted Midline Catheter Model Number Midline-Numerous.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981382
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026