510(k) · Cleared
Recalled · Class II · 2025V2 Injection Site
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 May 15, 1996 as substantially equivalent to K942988 (B. Braun of America, Inc., 1995) after a 160-day review. Its family tree reaches back 1 generation to 1995. 45 later devices descend from it. It has been recalled 27 times.
- Decided
- May 15, 1996
- Review
- 160 days
- Class
- Class II
- Product code
- FPA
- Recalls
- 27
- Predicates
- 1
Its longest line of descent runs back 1 generation to K942988 (1995). 45 later devices descend from it, 7 citing it directly.
- Root · 1 generation backK942988 Filtered Extension SetsB. Braun of America, Inc. · 1995 · Recalled
- This deviceK955585 V2 Injection SiteB.Braun Medical, Inc. · 1996
- Descendant · cites it directly · 35 of its ownK973167 Positive Pressure ConnectorIcu Medical, Inc. · 1997
- Descendant · cites it directly · 32 of its ownK031923 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 · 31 of its ownK991653 Invision-Plus Injection Port Connector SystemRymed Technologies, Inc. · 1999 · Recalled
- Descendant · 2 generations on · 29 of its ownK021692 CLC2000 Catheter Patency DeviceIcu Medical, Inc. · 2003
Showing 5 of 45 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 45 · See all- K973167Positive Pressure ConnectorIcu Medical, Inc. · 1997 · cites it directly35descendants
- K031923Ultrasite ValveB.Braun Medical, Inc. · 2003 · cites it directly32descendants
- K083723A6 Luer Access DeviceB.Braun Medical, Inc. · 2009 · cites it directly31descendants
- K991653Invision-Plus Injection Port Connector SystemRymed Technologies, Inc. · 1999 · 2 generations on31descendants
- K021692CLC2000 Catheter Patency DeviceIcu Medical, Inc. · 2003 · 2 generations on29descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K942988 | Filtered Extension Sets | B. Braun of America, Inc. | 1995 | 32 |
| 0 (this device) | K955585 | V2 Injection Site | B.Braun Medical, Inc. | 1996 | — |
| +1 | K973167 | Positive Pressure Connector | Icu Medical, Inc. | 1997 | — |
| +1 | K031923 | Ultrasite Valve | B.Braun Medical, Inc. | 2003 | — |
| +1 | K083723 | A6 Luer Access Device | B.Braun Medical, Inc. | 2009 | 66 |
| +2 | K991653 | Invision-Plus Injection Port Connector System | Rymed Technologies, Inc. | 1999 | 4 |
| +2 | K021692 | CLC2000 Catheter Patency Device | Icu Medical, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 4 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 5 | 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 |
|---|---|---|---|
| * | K942988 | Filtered Extension SetsSummary page 1…Set CLASSIFICATION NAME: General Hospital Class II, 80 FPA, Intravascular Administration Set 21 CFR 880.5860 SUBSTANTIAL EQUIVALENCE' TO: 510 (k) number Name Applicant K942988 Filtered Extension B. Braun of America Sets DEVICE DESCRIPTION: In accordance with section 510(k) for the Federal Food, Drug, a… | 1995 |
What descends from it? (45)
See all 457 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K973167 | Positive Pressure Connector | 1997 | 35 |
| K031923 | Ultrasite Valve | 2003 | 32 |
| K083723 | A6 Luer Access Device | 2009 | 31 |
| K024124 | System 100-UF 500 Circuit with in-Line Needleless Access Port | 2003 | 1 |
| K073396 | Antimicrobial Ultrasite Value, Ultrasite AG | 2008 | 0 |
| K021488 | Surecan Safety Huber Needle Infusion Sets | 2002 | 0 |
| K974145 | V3 Valve | 1998 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 29, 2025 | Class II | Z-0714-2026 | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). |
| Sep 15, 2022 | Class II | Z-0090-2023 | Process design | The extension set has a high probability of failure which could lead to possible leakage or detachment at the device's bonded joint during use. The issue may result in delay of therapy, increased risk of bloodstream infections (BSI), and… |
| Jan 8, 2014 | Class II | Z-0987-2014 | Process control | Complaints were received reporting leakage on certain lots of SAFSITE Injection Sites and IV Sets manufactured with SAFSITE Injection Sites.The SAFSITE Injection Site is intended to provide needle free access on IV and Extension Sets. |
| Aug 5, 2013 | Class II | Z-2166-2013 | Process control | Reports were received of an incorrectly assembled Outlook Safety Infusion System Burette Set (Product Code 375038), and the investigation determined that one of the ULTRASITE injection sites and corresponding low pressure backcheck valve… |
| Nov 24, 2009 | Not classified | Z-0685-2010 | Nonconforming Material/Component | System error 9 alarms. A System Error 9 alarm indicates a potential pressure loss in the pump cassette delivery chamber (chamber closest to the patient). This alarm is generated during the pumps initiation sequence and will not allow the… |
| Nov 24, 2009 | Not classified | Z-0684-2010 | Nonconforming Material/Component | System error 9 alarms. A System Error 9 alarm indicates a potential pressure loss in the pump cassette delivery chamber (chamber closest to the patient). This alarm is generated during the pumps initiation sequence and will not allow the… |
| Nov 24, 2009 | Not classified | Z-0686-2010 | Nonconforming Material/Component | System error 9 alarms. A System Error 9 alarm indicates a potential pressure loss in the pump cassette delivery chamber (chamber closest to the patient). This alarm is generated during the pumps initiation sequence and will not allow the… |
| Nov 24, 2009 | Not classified | Z-0706-2010 | Nonconforming Material/Component | System error 9 alarms. A System Error 9 alarm indicates a potential pressure loss in the pump cassette delivery chamber (chamber closest to the patient). This alarm is generated during the pumps initiation sequence and will not allow the… |
| Nov 24, 2009 | Not classified | Z-0708-2010 | Nonconforming Material/Component | System error 9 alarms. A System Error 9 alarm indicates a potential pressure loss in the pump cassette delivery chamber (chamber closest to the patient). This alarm is generated during the pumps initiation sequence and will not allow the… |
| Nov 24, 2009 | Not classified | Z-0678-2010 | Nonconforming Material/Component | System error 9 alarms. A System Error 9 alarm indicates a potential pressure loss in the pump cassette delivery chamber (chamber closest to the patient). This alarm is generated during the pumps initiation sequence and will not allow the… |
| Nov 24, 2009 | Not classified | Z-0707-2010 | Nonconforming Material/Component | System error 9 alarms. A System Error 9 alarm indicates a potential pressure loss in the pump cassette delivery chamber (chamber closest to the patient). This alarm is generated during the pumps initiation sequence and will not allow the… |
| Mar 27, 2009 | Not classified | Z-1428-2009 | Mixed-up of materials/components | Device defect is occlusion/no flow. |
| Mar 27, 2009 | Not classified | Z-1427-2009 | Mixed-up of materials/components | Device defect is occlusion/no flow. |
| Mar 27, 2009 | Not classified | Z-1430-2009 | Mixed-up of materials/components | Device defect is occlusion/no flow. |
| Mar 27, 2009 | Not classified | Z-1429-2009 | Mixed-up of materials/components | Device defect is occlusion/no flow. |
| Mar 27, 2009 | Not classified | Z-1431-2009 | Mixed-up of materials/components | Device defect is occlusion/no flow. |
| Mar 27, 2009 | Not classified | Z-1433-2009 | Mixed-up of materials/components | Device defect is occlusion/no flow. |
| Mar 27, 2009 | Not classified | Z-1432-2009 | Mixed-up of materials/components | Device defect is occlusion/no flow. |
| Sep 17, 2008 | Not classified | Z-0199-2009 | Employee error | Product was assembled incorrectly and connected to the wrong part. |
| Jun 30, 2008 | Not classified | Z-2410-2008 | Mixed-up of materials/components | incorrect burette was packaged with the product |
| Jun 30, 2008 | Not classified | Z-2407-2008 | Mixed-up of materials/components | incorrect burette was packaged with the product |
| Jun 30, 2008 | Not classified | Z-2411-2008 | Mixed-up of materials/components | incorrect burette was packaged with the product |
| Jun 30, 2008 | Not classified | Z-2413-2008 | Mixed-up of materials/components | incorrect burette was packaged with the product |
| Jun 30, 2008 | Not classified | Z-2412-2008 | Mixed-up of materials/components | incorrect burette was packaged with the product |
| Apr 18, 2007 | Not classified | Z-0818-2007 | Other | Secondary infusion backs up into primary container. |
| Apr 18, 2007 | Not classified | Z-0819-2007 | Other | Secondary infusion backs up into primary container. |
| Apr 14, 2003 | Not classified | Z-0933-03 | Other | possible leakage |
The 5 latest of 27 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- Of its descendants, K973167 (Icu Medical, Inc., 1997) has gone furthest, with 35 descendants of its own.
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 V2 Injection Site is designed to provide needle-free access on I.V. and Extension Sets as an alternative to latex injection sites or other needle-free access systems.
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/K955585 · printed Nov 5, 2026
Cite this page
510(k) Report. “K955585: V2 Injection Site.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K955585
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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