510(k) · Cleared
Recalled · Class II · 2025IV Sets not made with PVC
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 Mar 19, 2020 as substantially equivalent to K170595 (B.Braun Medical, Inc., 2017) and 1 other predicate after a 272-day review. Its family tree reaches back 8 generations to 1995. 4 of the 48 devices in its family, counting itself, have a Class I recall. It has been recalled once.
- Decided
- Mar 19, 2020
- Review
- 272 days
- Class
- Class II
- Product code
- FPA
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 8 generations to K942988 (1995). 47 ancestors in all, the oldest K780880 (1978). No later device cites it as a predicate yet. 4 of the 48 devices in this family, counting this one, have a Class I recall.
- Root · 8 generations backK942988 Filtered Extension SetsB. Braun of America, Inc. · 1995 · Recalled
- 7 generations backK955585 V2 Injection SiteB.Braun Medical, Inc. · 1996 · Recalled
- 6 generations backK973167 Positive Pressure ConnectorIcu Medical, Inc. · 1997
- 5 generations backK021692 CLC2000 Catheter Patency DeviceIcu Medical, Inc. · 2003
- 4 generations backK100434 Clave NeutronIcu Medical, Inc. · 2010 · Recalled
- 3 generations backK132413 MZ1000Care Fusion · 2013
- 2 generations backK140831 Maxzero Extension Set with Needless ConnectorCare Fusion · 2014
- 1 generation backK153293 Extension SetB.Braun Medical, Inc. · 2016 · Recalled
- This deviceK191658 IV Sets not made with PVCB.Braun Medical, Inc. · 2020
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K942988 | Filtered Extension Sets | B. Braun of America, Inc. | 1995 | 32 |
| −7 | K955585 | V2 Injection Site | B.Braun Medical, Inc. | 1996 | 27 |
| −6 | K973167 | Positive Pressure Connector | Icu Medical, Inc. | 1997 | — |
| −5 | K021692 | CLC2000 Catheter Patency Device | Icu Medical, Inc. | 2003 | — |
| −4 | K100434 | Clave Neutron | Icu Medical, Inc. | 2010 | 3 |
| −3 | K132413 | MZ1000 | Care Fusion | 2013 | — |
| −2 | K140831 | Maxzero Extension Set with Needless Connector | Care Fusion | 2014 | — |
| −1 | K153293 | Extension Set | B.Braun Medical, Inc. | 2016 | 8 |
| 0 (this device) | K191658 | IV Sets not made with PVC | B.Braun Medical, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1982 | 1 | 0 |
| 1984 | 2 | 0 |
| 1986 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 1 | 1 |
| 1997 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 1 |
| 2003 | 5 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 1 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 1 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 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.
4 devices in this family have a Class I recall. 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 |
|---|---|---|---|
| * | K170595 | IV Administration SetsSummary page 4…Set CLASSIFICATION: Set, Administration, Intravascular, 21 CFR 880.5440, Class II, Product Code FPA PREDICATE DEVICES: K170595, IV Administration Sets, B. Braun Medical Inc. K153293, Extension Set, B. Braun Medical Inc. DEVICE DESCRIPT… | 2017 |
| * | K153293 | Extension SetSummary page 4…21 CFR 880.5440, Class II, Product Code FPA PREDICATE DEVICES: K170595, IV Administration Sets, B. Braun Medical Inc. K153293, Extension Set, B. Braun Medical Inc. DEVICE DESCRIPTION: The IV Sets not made with PVC are gravity, single use, disposable, IV… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 29, 2025 | Class II | Z-0623-2026 | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K101677Hospira Infusion Blood SetsHospira, Inc. · 2010 · 3 generations back · ◆ in the 2010 ancestors bar of FIG. 18 Class I recalls
- K062700Infusomat Space Volumetric Infusion Pump SystemB.Braun Medical, Inc. · 2006 · 3 generations back · ◆ in the 2006 ancestors bar of FIG. 11 Class I recall
- K950419The Imed Orion Infusion Pump and Administration SetsImed Corp. · 1995 · 4 generations back · ◆ in the 1995 ancestors bar of FIG. 14 Class I recalls
- K994375Horizon LightB.Braun Medical, Inc. · 2000 · 5 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 25 years and passes through 4 companies; a new generation was cleared every 3.1 years on median.
- 28 of the 47 ancestors have a recall of any class; 4 have a Class I recall.
- 2 other devices also cite its predicate K170595.
How does its category compare?
All FPA devicesFPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 IV Administration Sets not made with PVC are intravenous administration sets intended for delivery of fluids from a container into a patient’s vascular system.
The IV Extension Sets not made with PVC may be used for direct injection, intermittent infusion, continuous infusion or aspiration of fluids, medications, blood and blood products.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191658 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191658: IV Sets not made with PVC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191658
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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