510(k) · Cleared
ClearedContrast Media Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
B.Braun Medical, Inc. · IZI System, X-Ray, Angiographic
Cleared on Mar 12, 1997 as substantially equivalent to K915678 (Merit Medical Systems, Inc., 1992) and 2 other predicates after a 485-day review. Its family tree reaches back 1 generation to 1991. 1 later device descends from it.
- Decided
- Mar 12, 1997
- Review
- 485 days
- Class
- Class II
- Product code
- IZI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K903493 (1991). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K052252Contrast Media Transfer SetsB.Braun Medical, Inc. · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K903493 | Namic Contrast Savings Delivery System | North American Instrument Corp. | 1991 | — |
| 0 (this device) | K955179 | Contrast Media Set | B.Braun Medical, Inc. | 1997 | — |
| +1 | K052252 | Contrast Media Transfer Sets | B.Braun Medical, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 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 IZI? 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 IZI device
- #1 K230727 SPY Portable Handheld Imaging (SPY-PHI) Systemscore 23.2 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K915678 | Merit Administration SetSummary page 1…eneral Hospital - Class II, 80 FPA, Intravascular IV Administration Set 21 CFR 880.5440 SUBSTANTIAL EQUIVALENCE® TO: I 510 (k) number Name Applicant i Merit Medical | K915678 Administra;ion Set K943181 Dispensing Pin B. Braun of America W/One Way Valve K903493B Contrast Savings NAMIC Delivery System… | 1992 |
| * | K943181 | Dispensing Pin with One-Way ValveSummary page 1…0 FPA, Intravascular IV Administration Set 21 CFR 880.5440 SUBSTANTIAL EQUIVALENCE® TO: I 510 (k) number Name Applicant i Merit Medical | K915678 Administra;ion Set K943181 Dispensing Pin B. Braun of America W/One Way Valve K903493B Contrast Savings NAMIC Delivery System DEVICE DESCRIPTION: In acco… | 1994 |
| * | K903493 | Namic Contrast Savings Delivery SystemSummary page 1…SUBSTANTIAL EQUIVALENCE® TO: I 510 (k) number Name Applicant i Merit Medical | K915678 Administra;ion Set K943181 Dispensing Pin B. Braun of America W/One Way Valve K903493B Contrast Savings NAMIC Delivery System DEVICE DESCRIPTION: In accordance with section 510(k) for the Federal Food, Drug, and… | 1991 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K052252 | Contrast Media Transfer Sets | 2005 | 0 |
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?
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K052252 (B.Braun Medical, Inc., 2005) has gone furthest, with 0 descendants of its own.
How does its category compare?
All IZI devicesIZI System, X-Ray, Angiographic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IZI
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IZI
81in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IZI
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IZI
2,171in 2025
MAUDE reports naming product code IZI, 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 | 7 | 28 | 6 | 92 |
| 2008 | 6 | 68 | 52 | 101 |
| 2009 | 2 | — | 18 | 132 |
| 2010 | 2 | — | 11 | 252 |
| 2011 | 4 | 104 | 6 | 377 |
| 2012 | 1 | — | 6 | 77 |
| 2013 | 1 | — | 6 | 58 |
| 2014 | 4 | 111 | 5 | 123 |
| 2015 | 0 | — | 14 | 36 |
| 2016 | 1 | — | 7 | 102 |
| 2017 | 2 | — | 1 | 88 |
| 2018 | 2 | — | 2 | 49 |
| 2019 | 2 | — | 2 | 30 |
| 2020 | 1 | — | 2 | 14 |
| 2021 | 1 | — | 1 | 29 |
| 2022 | 1 | — | 0 | 265 |
| 2023 | 3 | 81 | 0 | 1,204 |
| 2024 | 2 | — | 0 | 1,332 |
| 2025 | 2 | — | 0 | 2,171 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The Contrast Media Set is for reducing contrast waste by allowing one bottle of contrast to be used on more than one patient.
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/K955179 · printed Nov 4, 2026
Cite this page
510(k) Report. “K955179: Contrast Media Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K955179
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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