510(k) Report

510(k) · Cleared

Cleared

Brewer Heave-Duty I.V. Stand W/Foot Operated Pnuem

K850245510(k) TraditionalCleared Feb 7, 198516-day reviewClass I21 CFR 880.6990

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

E.F. Brewer Co. · FOX Stand, Infusion

Cleared on Feb 7, 1985 after a 16-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Feb 7, 1985
Review
16 days
Class
Class I
Product code
FOX
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 1998: 1 descendant cleared1990200020102020
  1. This deviceK850245 Brewer Heave-Duty I.V. Stand W/Foot Operated PnuemE.F. Brewer Co. · 1985
  2. Descendant · cites it directly · 0 of its ownK980336 IV StandsClinton Industries, Inc. · 1998

Most influential descendants

Showing 1 of 1 · See all
  • K980336IV StandsClinton Industries, Inc. · 1998 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K850245Brewer Heave-Duty I.V. Stand W/Foot Operated PnuemE.F. Brewer Co.1985—
+1K980336IV StandsClinton Industries, Inc.1998—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
FIG. 1 — Lineage of K850245, 1985–1998Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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.

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  • Recall history across each candidate’s familyin the report
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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? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K980336IV StandsClinton Industries, Inc.19980

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, K980336 (Clinton Industries, Inc., 1998) has gone furthest, with 0 descendants of its own.

How does its category compare?

All FOX devices

FOX 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

2015: 12016: 1
2007high 1 (2015) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FOX

2in 2025

2007: 42008: 32009: 22010: 32011: 102012: 52013: 72014: 22015: 32016: 22017: 82018: 172019: 232020: 1122021: 1732022: 122023: 32024: 62025: 2
2007high 173 (2021) · low 2 (2009)2025

MAUDE reports naming product code FOX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—04
20080—03
20090—02
20100—03
20110—010
20120—05
20130—07
20140—02
20150—13
20160—12
20170—08
20180—017
20190—023
20200—0112
20210—0173
20220—012
20230—03
20240—06
20250—02
20260—0—
Cite this page

510(k) Report. “K850245: Brewer Heave-Duty I.V. Stand W/Foot Operated Pnuem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K850245

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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