510(k) · Cleared
ClearedUltrasite Valve
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 11, 2003 as substantially equivalent to K955585 (B.Braun Medical, Inc., 1996) after a 49-day review. Its family tree reaches back 2 generations to 1995. 32 later devices descend from it.
- Decided
- Aug 11, 2003
- Review
- 49 days
- Class
- Class II
- Product code
- FPA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K942988 (1995). 32 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK942988 Filtered Extension SetsB. Braun of America, Inc. · 1995 · Recalled
- 1 generation backK955585 V2 Injection SiteB.Braun Medical, Inc. · 1996 · Recalled
- This deviceK031923 Ultrasite ValveB.Braun Medical, Inc. · 2003
- Descendant · cites it directly · 31 of its ownK083723 A6 Luer Access DeviceB.Braun Medical, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 28 of its ownK100434 Clave NeutronIcu Medical, Inc. · 2010 · Recalled
- Descendant · 3 generations on · 26 of its ownK132413 MZ1000Care Fusion · 2013
- Descendant · 4 generations on · 13 of its ownK140831 Maxzero Extension Set with Needless ConnectorCare Fusion · 2014
- Descendant · 4 generations on · 6 of its ownK170336 BD Nexiva Closed IV Catheter System (Single Port) with MaxZero…Becton, Dickinson and Company · 2017
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 32 · See all- K083723A6 Luer Access DeviceB.Braun Medical, Inc. · 2009 · cites it directly31descendants
- K100434Clave NeutronIcu Medical, Inc. · 2010 · 2 generations on28descendants
- K132413MZ1000Care Fusion · 2013 · 3 generations on26descendants
- K140831Maxzero Extension Set with Needless ConnectorCare Fusion · 2014 · 4 generations on13descendants
- K170336BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless ConnectorBecton, Dickinson and Company · 2017 · 4 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K942988 | Filtered Extension Sets | B. Braun of America, Inc. | 1995 | 32 |
| −1 | K955585 | V2 Injection Site | B.Braun Medical, Inc. | 1996 | 27 |
| 0 (this device) | K031923 | Ultrasite Valve | B.Braun Medical, Inc. | 2003 | — |
| +1 | K083723 | A6 Luer Access Device | B.Braun Medical, Inc. | 2009 | 66 |
| +2 | K100434 | Clave Neutron | Icu Medical, Inc. | 2010 | 3 |
| +3 | K132413 | MZ1000 | Care Fusion | 2013 | — |
| +4 | K140831 | Maxzero Extension Set with Needless Connector | Care Fusion | 2014 | — |
| +4 | K170336 | BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless… | Becton, Dickinson and Company | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 4 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 6 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 2 | 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? (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 |
|---|---|---|---|
| * | K955585 | V2 Injection SiteSummary page 1…' 'on S a product code F'PA PREDXCATE DEVICE: B.Bmun M d c a l I~c.'sUltrasit~Valve (prcviousfy lamam as V2 Injection Site CK955585) DESCRIPTION 8, Braun Medical's ultrasite@ Valve is intended for aspirotion, injwticm ar gmvity/pum… | 1996 |
What descends from it? (32)
See all 321 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083723 | A6 Luer Access Device | 2009 | 31 |
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 8 years and passes through 2 companies; a new generation was cleared every 7.2 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K083723 (B.Braun Medical, Inc., 2009) has gone furthest, with 31 descendants of its own.
- 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.
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 Ultrasite® Valve is intended for aspiration, injection or gravity/pump flow of fluids upon insertion of a male luer fitting. The Ultrasite Valve may also be used with power injectors for which the maximum pressure setting is 300 psi. When used with a power injector, the Ultrasite Valve must be secured to other devices with a luer lock connection; other devices must also be rated for 300 psi. The Ultrasite Valve is designed to aid in the prevention of needlestick injury.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031923 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031923: Ultrasite Valve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031923
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