510(k) · Cleared
Recalled · Class II · 2025Extension Set
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 Apr 6, 2016 as substantially equivalent to K083472 (Medegen, Inc., 2008) and 1 other predicate after a 145-day review. Its family tree reaches back 7 generations to 1995. 3 later devices descend from it. It has been recalled 8 times.
- Decided
- Apr 6, 2016
- Review
- 145 days
- Class
- Class II
- Product code
- FPA
- Recalls
- 8
- Predicates
- 2
Its longest line of descent runs back 7 generations to K942988 (1995). 17 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK942988 Filtered Extension SetsB. Braun of America, Inc. · 1995 · Recalled
- 6 generations backK955585 V2 Injection SiteB.Braun Medical, Inc. · 1996 · Recalled
- 5 generations backK973167 Positive Pressure ConnectorIcu Medical, Inc. · 1997
- 4 generations backK021692 CLC2000 Catheter Patency DeviceIcu Medical, Inc. · 2003
- 3 generations backK100434 Clave NeutronIcu Medical, Inc. · 2010 · Recalled
- 2 generations backK132413 MZ1000Care Fusion · 2013
- 1 generation backK140831 Maxzero Extension Set with Needless ConnectorCare Fusion · 2014
- This deviceK153293 Extension SetB.Braun Medical, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK230528 Extension SetMedcaptain Life Science Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK202618 IV Administration SetsB.Braun Medical, Inc. · 2021 · Recalled
- Descendant · cites it directly · 0 of its ownK191658 IV Sets not made with PVCB.Braun Medical, Inc. · 2020 · Recalled
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K942988 | Filtered Extension Sets | B. Braun of America, Inc. | 1995 | 32 |
| −6 | K955585 | V2 Injection Site | B.Braun Medical, Inc. | 1996 | 27 |
| −5 | K973167 | Positive Pressure Connector | Icu Medical, Inc. | 1997 | — |
| −4 | K021692 | CLC2000 Catheter Patency Device | Icu Medical, Inc. | 2003 | — |
| −3 | K100434 | Clave Neutron | Icu Medical, Inc. | 2010 | 3 |
| −2 | K132413 | MZ1000 | Care Fusion | 2013 | — |
| −1 | K140831 | Maxzero Extension Set with Needless Connector | Care Fusion | 2014 | — |
| 0 (this device) | K153293 | Extension Set | B.Braun Medical, Inc. | 2016 | — |
| +1 | K230528 | Extension Set | Medcaptain Life Science Co., Ltd. | 2023 | — |
| +1 | K202618 | IV Administration Sets | B.Braun Medical, Inc. | 2021 | 1 |
| +1 | K191658 | IV Sets not made with PVC | B.Braun Medical, Inc. | 2020 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K083472 | Medegen Pressure Rated Extension SetsSummary page 4…istration Set CLASSIFICATION: Class II, Product Code FPA, 21 CFR §880.5440, Intravascular administration set PREDICATE DEVICES: K083472 Medegen, Incorporated K140831 CareFusion (formerly Medegen, Incorporated) Class II, Product… | 2008 |
| * | K140831 | Maxzero Extension Set with Needless ConnectorSummary page 4…II, Product Code FPA, 21 CFR §880.5440, Intravascular administration set PREDICATE DEVICES: K083472 Medegen, Incorporated K140831 CareFusion (formerly Medegen, Incorporated) Class II, Product Code FPA, 21 CFR §880.5440 DESCRIPTION: B. B… | 2014 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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-0611-2026 | 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-0612-2026 | 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-0665-2026 | 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-0673-2026 | 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-0630-2026 | 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-0669-2026 | 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-0674-2026 | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). |
| 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. |
The 5 latest of 8 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
- 10 of the 17 ancestors have a recall of any class.
- Of its descendants, K230528 (Medcaptain Life Science Co., Ltd., 2023) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K083472.
How does its category compare?
All FPA devicesFPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
B. Braun Extension Sets may be used for direct injection, intermittent infusion, continuous infusion or aspiration of fluids, medications, blood and blood products. Select sets may be used with power injector procedures to a maximum pressure of 400 psi and a maximum flow rate of 15 mL per second. B. Braun's optional stabilization component on an extension set provides stability to an intravascular catheter by supporting the patient connector. B. Braun Extension Sets may be used for any patient population.
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/K153293 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153293: Extension Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153293
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