510(k) · Cleared
ClearedAntimicrobial Ultrasite Value, Ultrasite AG
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
B.Braun Medical, Inc. · FPA Set, Administration, Intravascular
Cleared on Aug 7, 2008 as substantially equivalent to K955585 (B.Braun Medical, Inc., 1996) and 1 other predicate after a 248-day review. Its family tree reaches back 3 generations to 1986.
- Decided
- Aug 7, 2008
- Review
- 248 days
- Class
- Class II
- Product code
- FPA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K861563 (1986). 7 ancestors in all, the oldest K862691 (1986). No later device cites it as a predicate yet.
- Root · 3 generations backK861563 Vitaguard Percutaneous Infection Control KitVitaphore Corp. · 1986
- 2 generations backK954970 Stopcock & Luer Lock PlugMedex, Inc. · 1996 · Recalled
- 1 generation backK053405 BacstopElcam Medical Acal · 2006
- This deviceK073396 Antimicrobial Ultrasite Value, Ultrasite AGB.Braun Medical, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K861563 | Vitaguard Percutaneous Infection Control Kit | Vitaphore Corp. | 1986 | — |
| −2 | K954970 | Stopcock & Luer Lock Plug | Medex, Inc. | 1996 | 1 |
| −1 | K053405 | Bacstop | Elcam Medical Acal | 2006 | — |
| 0 (this device) | K073396 | Antimicrobial Ultrasite Value, Ultrasite AG | B.Braun Medical, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2002 | 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 FPA? 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 FPA device
- #1 K243841 Sparta Infusion Set for Insulinscore 13.4 · 3 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 |
|---|---|---|---|
| * | K955585 | V2 Injection SiteSummary page 1…Class II, Product Code FPA, Intravascular Administration Set, 21 CFR 880.5440 PREDICATE DEVICES: B. Braun Medical Inc. Ultrasite Valve 510(k) K955585 Elcam Medical Antimicrobial Stopcock 510(k) K053405 DESCRIPTION: B. Braun's Antibacterial Ultrasite® Valv… | 1996 |
| * | K053405 | BacstopSummary page 1…CFR 880.5440 PREDICATE DEVICES: B. Braun Medical Inc. Ultrasite Valve 510(k) K955585 Elcam Medical Antimicrobial Stopcock 510(k) K053405 DESCRIPTION: B. Braun's Antibacterial Ultrasite® Valve is an individually packaged, sterile, non-pyrogeni… | 2006 |
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?
- The line of descent spans 22 years and passes through 4 companies; a new generation was cleared every 9.7 years on median.
- 4 of the 7 ancestors have a recall of any class.
- 6 other devices also cite its predicate K955585.
How does its category compare?
All FPA devicesFPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · FPA
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FPA
225in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FPA
98in 2025
Class I (17 since 2007) Class II/III not classified
Adverse event reports per year · FPA
34,506in 2025
MAUDE reports naming product code FPA, 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 | 16 | 75 | 17 | 1,499 |
| 2008 | 18 | 89 | 15 | 1,941 |
| 2009 | 10 | 166 | 166 | 2,512 |
| 2010 | 23 | 120 | 58 | 2,537 |
| 2011 | 12 | 87 | 28 | 4,407 |
| 2012 | 21 | 96 | 16 (4) | 4,930 |
| 2013 | 13 | 90 | 64 | 4,651 |
| 2014 | 22 | 89 | 24 | 4,695 |
| 2015 | 17 | 123 | 6 | 6,625 |
| 2016 | 12 | 195 | 10 | 8,470 |
| 2017 | 17 | 240 | 13 | 6,462 |
| 2018 | 4 | 177 | 4 | 6,574 |
| 2019 | 7 | 161 | 13 | 11,227 |
| 2020 | 10 | 327 | 107 | 9,563 |
| 2021 | 13 | 186 | 1 | 10,414 |
| 2022 | 14 | 213 | 9 (5) | 13,393 |
| 2023 | 14 | 340 | 12 (4) | 10,916 |
| 2024 | 7 | 244 | 13 (1) | 47,210 |
| 2025 | 11 | 225 | 98 (1) | 34,506 |
| 2026 | 5 | 266 | 10 (2) | — |
What is it indicated for?
The B. Braun Antibacterial Ultrasite Valve (Ultrasite Ag) is intended for aspiration, injection or gravity/pump flow of IV fluids upon insertion of a male luer fitting. Not intended for use with power injectors.
The Antibacterial Ultrasite Valve contains a silver based compound which may help to reduce bacterial growth on the surface and within the fluid path of the device.
Testing with Ultrasite Ag Valve demonstrated antibacterial effectiveness against Pseudomonas aeruginosa,Kebsiella pneumoniae,and Enterobacteraerogenes over 96 hours.
The Antibacterial Ultrasite Valve is not intended for use in the treatment of existing infections.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073396 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073396: Antimicrobial Ultrasite Value, Ultrasite AG.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073396
Report an extraction error
Are you the manufacturer?
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