510(k) · Cleared
Recalled · Class II · 2026Filtered Extension Sets
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
B. Braun of America, Inc. · FPA Set, Administration, Intravascular
Cleared on Jul 14, 1995 after a 389-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 46 later devices descend from it. It has been recalled 32 times.
- Decided
- Jul 14, 1995
- Review
- 389 days
- Class
- Class II
- Product code
- FPA
- Recalls
- 32
- Predicates
- 0
46 later devices descend from it, 1 citing it directly.
- This deviceK942988 Filtered Extension SetsB. Braun of America, Inc. · 1995
- Descendant · cites it directly · 45 of its ownK955585 V2 Injection SiteB.Braun Medical, Inc. · 1996 · Recalled
- Descendant · 2 generations on · 35 of its ownK973167 Positive Pressure ConnectorIcu Medical, Inc. · 1997
- Descendant · 2 generations on · 32 of its ownK031923 Ultrasite ValveB.Braun Medical, Inc. · 2003
- Descendant · 2 generations on · 31 of its ownK083723 A6 Luer Access DeviceB.Braun Medical, Inc. · 2009 · Recalled
- Descendant · 3 generations on · 31 of its ownK991653 Invision-Plus Injection Port Connector SystemRymed Technologies, Inc. · 1999 · Recalled
Showing 5 of 46 descendants. See all descendants
Descendants cleared per year
1996high 6 (2021) · low 0 (2000)2026
Most influential descendants
Showing 5 of 46 · See all- K955585V2 Injection SiteB.Braun Medical, Inc. · 1996 · cites it directly45descendants
- K973167Positive Pressure ConnectorIcu Medical, Inc. · 1997 · 2 generations on35descendants
- K031923Ultrasite ValveB.Braun Medical, Inc. · 2003 · 2 generations on32descendants
- K083723A6 Luer Access DeviceB.Braun Medical, Inc. · 2009 · 2 generations on31descendants
- K991653Invision-Plus Injection Port Connector SystemRymed Technologies, Inc. · 1999 · 3 generations on31descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K942988 | Filtered Extension Sets | B. Braun of America, Inc. | 1995 | — |
| +1 | K955585 | V2 Injection Site | B.Braun Medical, Inc. | 1996 | 27 |
| +2 | K973167 | Positive Pressure Connector | Icu Medical, Inc. | 1997 | — |
| +2 | K031923 | Ultrasite Valve | B.Braun Medical, Inc. | 2003 | — |
| +2 | K083723 | A6 Luer Access Device | B.Braun Medical, Inc. | 2009 | 66 |
| +3 | K991653 | Invision-Plus Injection Port Connector System | Rymed Technologies, Inc. | 1999 | 4 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 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), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (46)
See all 461 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K955585 | V2 Injection Site | 1996 | 45 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 14, 2026 | Class II | Z-0193-2027 | Process control | Potential for leakage and backflow at the Safsite valve. |
| Aug 4, 2026 | Class II | Z-3089-2026 | Under Investigation by firm | Specific lots of Discofix Stopcock Sets recalled due to an incorrect expiration date printed on the carton shipper label. |
| Oct 29, 2025 | Class II | Z-0632-2026 | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). |
| Oct 29, 2025 | Class II | Z-0633-2026 | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). |
| Oct 29, 2025 | Class II | Z-0634-2026 | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). |
| Oct 29, 2025 | Class II | Z-0628-2026 | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). |
| Oct 29, 2025 | Class II | Z-0663-2026 | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). |
| Oct 29, 2025 | Class II | Z-0604-2026 | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). |
| Oct 29, 2025 | Class II | Z-0692-2026 | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). |
| Oct 29, 2025 | Class II | Z-0626-2026 | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). |
| Oct 29, 2025 | Class II | Z-0635-2026 | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). |
| Oct 29, 2025 | Class II | Z-0653-2026 | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). |
| Oct 29, 2025 | Class II | Z-0687-2026 | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). |
| Oct 29, 2025 | Class II | Z-0703-2026 | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). |
| Oct 29, 2025 | Class II | Z-0715-2026 | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). |
| Oct 29, 2025 | Class II | Z-0716-2026 | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). |
| Oct 29, 2025 | Class II | Z-0704-2026 | 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-0092-2023 | Process design | The extension set has a high probability of potential 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… |
| Sep 15, 2022 | Class II | Z-0091-2023 | 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 31, 2022 | Class II | Z-0727-2022 | Under Investigation by firm | This lot may have an elevated risk of leakage from the Air-Inlet Filter of the device. Leakage of the Air-Inlet Filter may increase the risk of decreasing the dose of medication delivered to the patient, cause delays in treatment due to… |
| Aug 10, 2021 | Class II | Z-2552-2021 | Under Investigation by firm | Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections. |
| Aug 10, 2021 | Class II | Z-2546-2021 | Under Investigation by firm | Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections. |
| Mar 15, 2021 | Class II | Z-1509-2021 | Under Investigation by firm | BBMI has identified through complaints the potential for the extension set to become occluded or unable to prime. |
| May 29, 2014 | Class II | Z-2022-2014 | Process control | Complaints were received that reported the stopcock of some Stopcock Extension Sets are assembled in the reverse position, resulting in the stopcock being closed when set in the open position and vise versa. |
| 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. |
| Nov 24, 2009 | Not classified | Z-0671-2010 | 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-0673-2010 | 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-0670-2010 | 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-0672-2010 | 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-0674-2010 | 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… |
| Jun 30, 2008 | Not classified | Z-2408-2008 | Mixed-up of materials/components | incorrect burette was packaged with the product |
| Apr 14, 2003 | Not classified | Z-0933-03 | Other | possible leakage |
The 5 latest of 32 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K955585 (B.Braun Medical, Inc., 1996) has gone furthest, with 45 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
2007high 23 (2010) · low 4 (2018)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · FPA
225in 2025
2007high 340 (2023) · low 75 (2007)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FPA
98in 2025
2007high 166 (2009) · low 1 (2021)2026
Class I (17 since 2007) Class II/III not classified
Adverse event reports per year · FPA
34,506in 2025
2007high 47,210 (2024) · low 1,499 (2007)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) | — |
https://510kreport.com/device/K942988 · printed Nov 6, 2026
Cite this page
510(k) Report. “K942988: Filtered Extension Sets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K942988
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026