510(k) · Cleared
Recalled · Class II · 2021Deltaven Fast Flash Closed I.V. Catheter Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Delta Med Spa · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on Aug 26, 2020 as substantially equivalent to K171530 (Delta Med Spa, 2017) after a 194-day review. Its family tree reaches back 3 generations to 2004. It has been recalled 2 times.
- Decided
- Aug 26, 2020
- Review
- 194 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 3 generations to K032843 (2004). No later device cites it as a predicate yet.
- Root · 3 generations backK032843 Nexiva Closed IV Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc. · 2004 · Recalled
- 2 generations backK102520 BD Nexiva Closed IV Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc. · 2011
- 1 generation backK171530 Deltaven XiV Max, Deltaven XiV Max FFDelta Med Spa · 2017 · Recalled
- This deviceK200373 Deltaven Fast Flash Closed I.V. Catheter SystemsDelta Med Spa · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K032843 | Nexiva Closed IV Catheter System | Becton Dickinson Infusion Therapy Systems, Inc. | 2004 | 17 |
| −2 | K102520 | BD Nexiva Closed IV Catheter System | Becton Dickinson Infusion Therapy Systems, Inc. | 2011 | — |
| −1 | K171530 | Deltaven XiV Max, Deltaven XiV Max FF | Delta Med Spa | 2017 | 3 |
| 0 (this device) | K200373 | Deltaven Fast Flash Closed I.V. Catheter Systems | Delta Med Spa | 2020 | — |
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 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? (1)
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 |
|---|---|---|---|
| * | K171530 | Deltaven XiV Max, Deltaven XiV Max FFSummary page 4…21 CFR 880.5200 Product Code: FOZ Device Class: Class II Predicate Device: K171530; Deltaven Closed I.V. Catheter Systems Device Description: The devices consist of an over-the-needle, peripheral intravascular… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 21, 2021 | Class II | Z-2296-2021 | Process control | Problems related to the sterilization of the medical devices; possible missing sterility of the medical device |
| Jun 21, 2021 | Class II | Z-2305-2021 | Process control | Problems related to the sterilization of the medical devices; possible missing sterility of the medical device |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 2 companies; a new generation was cleared every 6.9 years on median.
- 2 of the 3 ancestors have a recall of any class.
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. 2020, this device’s year, is highlighted.
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?
Deltaven Fast Flash Closed I.V. Catheter systems are catheters for short-term peripheral venous access that allow the collection of blood samples and administration of fluids intravascularly. Deltaven Fast Flash Closed I.V. Catheter systems are equipped with a passive system for the prevention of accidental needlestick injuries. Blood is contained within the device during the catheter insertion process, aiding the prevention of blood exposure. The device…
Read the full statement (145 words)
Deltaven Fast Flash Closed I.V. Catheter systems are catheters for short-term peripheral venous access that allow the collection of blood samples and administration of fluids intravascularly.
Deltaven Fast Flash Closed I.V. Catheter systems are equipped with a passive system for the prevention of accidental needlestick injuries.
Blood is contained within the device during the catheter insertion process, aiding the prevention of blood exposure. The device can be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure.
Deltaven Fast Flash Closed I.V. Catheter systems 16-24 gauge catheters are suitable for use with pressure injectors rated for a maximum of 330 psi when the access ports and stopcocks are removed and a direct connection is made with the proximal luer lock connector.
Deltaven Fast Flash Closed I.V. Catheter systems 26G are not suitable for the administration at high pressure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200373 · printed Nov 4, 2026
Cite this page
510(k) Report. “K200373: Deltaven Fast Flash Closed I.V. Catheter Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K200373
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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