510(k) · Cleared
ClearedIV Stands
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Clinton Industries, Inc. · FOX Stand, Infusion
Cleared on Apr 6, 1998 as substantially equivalent to K823270 (E.F. Brewer Co., 1982) and 1 other predicate after a 68-day review. Its family tree reaches back 1 generation to 1982.
- Decided
- Apr 6, 1998
- Review
- 68 days
- Class
- Class I
- Product code
- FOX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K823270 (1982). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK823270 Heavy-Duty I.V. StandE.F. Brewer Co. · 1982
- This deviceK980336 IV StandsClinton Industries, Inc. · 1998
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) | K980336 | IV Stands | Clinton Industries, Inc. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 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 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? (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 |
|---|---|---|---|
| * | K823270 | Heavy-Duty I.V. StandSummary page 3…. are substantially equivalent to a product line of IV Stands marketed by The Brewer Company. We believe that these Stands are covered in the E. F. Brewer 510(k) numbers K823270 and K850245. Both the Clinton Industries, Inc. and The Brewer Company IV Stands are used for hanging IV and other solutions, whi… | 1982 |
| * | K850245 | Brewer Heave-Duty I.V. Stand W/Foot Operated PnuemSummary page 3…ntially equivalent to a product line of IV Stands marketed by The Brewer Company. We believe that these Stands are covered in the E. F. Brewer 510(k) numbers K823270 and K850245. Both the Clinton Industries, Inc. and The Brewer Company IV Stands are used for hanging IV and other solutions, which are being… | 1985 |
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?
- None of the 2 ancestors has a 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 IV Stands and accessories are intended for hanging IV and other solution bags which are being administered to patients. The IV Stands are also used for hanging or supporting Infusion Pumps and other items that are used during IV administration, surgery, or patient care.
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/K980336 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980336: IV Stands.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980336
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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