510(k) · Cleared
ClearedMedrad Contrast Holder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medrad, Inc. · FOX Stand, Infusion
Cleared on Feb 25, 1997 as substantially equivalent to K823270 (E.F. Brewer Co., 1982) after a 90-day review. Its family tree reaches back 1 generation to 1982.
- Decided
- Feb 25, 1997
- Review
- 90 days
- Class
- Class I
- Product code
- FOX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K823270 (1982). No later device cites it as a predicate yet.
- Root · 1 generation backK823270 Heavy-Duty I.V. StandE.F. Brewer Co. · 1982
- This deviceK964782 Medrad Contrast HolderMedrad, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K823270 | Heavy-Duty I.V. Stand | E.F. Brewer Co. | 1982 | — |
| 0 (this device) | K964782 | Medrad Contrast Holder | Medrad, Inc. | 1997 | — |
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 FOX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K823270 | Heavy-Duty I.V. StandSummary page 1…Holder Classification Name: Unknown Predicate Device Information: The Medrad Contrast Holder is compared to and is substantially equivalent to the EF Brewer IV Stand (K823270) as both devices are intended to hold IV/Contrast containers during examinations. Both the predicate device and the Medrad Contra… | 1982 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K823270.
How does its category compare?
All FOX devicesFOX Stand, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FOX
FDA has decided no FOX device since 2007.
Median 510(k) review, days · FOX
Too few FOX 510(k)s in any year since 2007 to give a median.
Recalls per year · FOX
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FOX
2in 2025
MAUDE reports naming product code FOX, 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 | 0 | — | 0 | 4 |
| 2008 | 0 | — | 0 | 3 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 10 |
| 2012 | 0 | — | 0 | 5 |
| 2013 | 0 | — | 0 | 7 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 1 | 3 |
| 2016 | 0 | — | 1 | 2 |
| 2017 | 0 | — | 0 | 8 |
| 2018 | 0 | — | 0 | 17 |
| 2019 | 0 | — | 0 | 23 |
| 2020 | 0 | — | 0 | 112 |
| 2021 | 0 | — | 0 | 173 |
| 2022 | 0 | — | 0 | 12 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 6 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Medrad Contrast Holders are an accessory device intended to be used in conjunction with Mexlrad injectors. The device is designed to aid in the transfer of common contrast media or flushing agents such as saline to the sytinge. Users of this device are to be medical professionals trained in CT, MR ,Angiographic Procedures, and are expected to have a good understanding of the events leading up to and including the use of the device. The Medrad Contrast Holder replaces the need for a separate contrast holder or Medrad Contrast Holder and is designed specifically for use with Medrad injectors.
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/K964782 · printed Nov 4, 2026
Cite this page
510(k) Report. “K964782: Medrad Contrast Holder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964782
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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