510(k) · Cleared
ClearedNamic Contrast Savings Delivery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
North American Instrument Corp. · IZI System, X-Ray, Angiographic
Cleared on Mar 26, 1991 after a 235-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 42 later devices descend from it.
- Decided
- Mar 26, 1991
- Review
- 235 days
- Class
- Class II
- Product code
- IZI
- Recalls
- None
- Predicates
- 0
42 later devices descend from it, 5 citing it directly.
- This deviceK903493 Namic Contrast Savings Delivery SystemNorth American Instrument Corp. · 1991
- Descendant · cites it directly · 39 of its ownK961794 Fluid Administration Set - Contrast ManagerMerit Medical Systems, Inc. · 1996
- Descendant · cites it directly · 20 of its ownK984231 Angiographic Contrast Management System, Model Part a and Part BInvasatec · 2000 · Recalled
- Descendant · 2 generations on · 15 of its ownK022431 Medrad Transfer SetMedrad, Inc. · 2002
- Descendant · 2 generations on · 14 of its ownK052744 C2000 Automated Manifold KitAcist Medical Systems, Inc. · 2005 · Recalled
- Descendant · 3 generations on · 13 of its ownK131478 Contrast Conservation SystemOsprey Medical, Inc. · 2013
Showing 5 of 42 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 42 · See all- K961794Fluid Administration Set - Contrast ManagerMerit Medical Systems, Inc. · 1996 · cites it directly39descendants
- K984231Angiographic Contrast Management System, Model Part a and Part BInvasatec · 2000 · cites it directly20descendants
- K022431Medrad Transfer SetMedrad, Inc. · 2002 · 2 generations on15descendants
- K052744C2000 Automated Manifold KitAcist Medical Systems, Inc. · 2005 · 2 generations on14descendants
- K131478Contrast Conservation SystemOsprey Medical, Inc. · 2013 · 3 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K903493 | Namic Contrast Savings Delivery System | North American Instrument Corp. | 1991 | — |
| +1 | K961794 | Fluid Administration Set - Contrast Manager | Merit Medical Systems, Inc. | 1996 | — |
| +1 | K984231 | Angiographic Contrast Management System, Model Part a and Part B | Invasatec | 2000 | 4 |
| +2 | K022431 | Medrad Transfer Set | Medrad, Inc. | 2002 | — |
| +2 | K052744 | C2000 Automated Manifold Kit | Acist Medical Systems, Inc. | 2005 | 1 |
| +3 | K131478 | Contrast Conservation System | Osprey Medical, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 5 | 0 |
| 2016 | 2 | 0 |
| 2017 | 4 | 0 |
| 2018 | 4 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 1 | 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 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (42)
See all 425 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K961794 (Merit Medical Systems, Inc., 1996) has gone furthest, with 39 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 | — |
https://510kreport.com/device/K903493 · printed Nov 6, 2026
Cite this page
510(k) Report. “K903493: Namic Contrast Savings Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K903493
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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