510(k) Report

510(k) · Cleared

Cleared

Contrast Control Device

K982123510(k) TraditionalCleared Jul 21, 199835-day reviewClass II21 CFR 880.5440

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

Medex, Inc. · FPA Set, Administration, Intravascular

Cleared on Jul 21, 1998 as substantially equivalent to K883318 (Valleylab, Inc., 1988) and 1 other predicate after a 35-day review. Its family tree reaches back 1 generation to 1988.

Decided
Jul 21, 1998
Review
35 days
Class
Class II
Product code
FPA
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K883318 (1988). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1991: 1 other ancestorK883318 · Valleylab I.V. Administration Sets · Valleylab, Inc. · 19881985199019952000
Other ancestors, by generation 1 generation back: 1 other ancestor K883318 · Valleylab I.V. Administration Sets · Valleylab, Inc. · 19880
  1. Root · 1 generation backK883318 Valleylab I.V. Administration SetsValleylab, Inc. · 1988
  2. This deviceK982123 Contrast Control DeviceMedex, Inc. · 1998
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K883318Valleylab I.V. Administration SetsValleylab, Inc.1988—
0 (this device)K982123Contrast Control DeviceMedex, Inc.1998—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
FIG. 1 — Lineage of K982123, 1988–1998Source: 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), 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 FPA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

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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.

TypeNumberDeviceApplicantDecidedRecalls
*K883318Valleylab I.V. Administration Sets
Summary page 1
…Control Device, for purposes as defined under Section 510(k) of the Federal Food, Drug and Cosmetic Act, are substantially equivalent to the Medex IV Administration Set, K883318 and pre-amendment (primary predicate). Additionally, the Contrast Control Device is substantially equivalent to the Namic Contras…
Valleylab, Inc.1988—
*K903493Namic Contrast Savings Delivery System
Summary page 1
…istration Set, K883318 and pre-amendment (primary predicate). Additionally, the Contrast Control Device is substantially equivalent to the Namic Contrast Savings System, K903493 (secondary predicate). 807.92(a)(4) Description of the Premarket Notification Device and 807.92 (a) (5) Intended Use The CCD is…
North American Instrument Corp.1991—

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.

How does its category compare?

All FPA devices

FPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FPA

11in 2025

2007: 162008: 182009: 102010: 232011: 122012: 212013: 132014: 222015: 172016: 122017: 172018: 42019: 72020: 102021: 132022: 142023: 142024: 72025: 112026 (partial year): 5
2007high 23 (2010) · low 4 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FPA

225in 2025

2007: 75 days median2008: 89 days median2009: 166 days median2010: 120 days median2011: 87 days median2012: 96 days median2013: 90 days median2014: 89 days median2015: 123 days median2016: 195 days median2017: 240 days median2018: 177 days median2019: 161 days median2020: 327 days median2021: 186 days median2022: 213 days median2023: 340 days median2024: 244 days median2025: 225 days median2026 (partial year): 266 days median
2007high 340 (2023) · low 75 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FPA

98in 2025

2007: 172008: 152009: 1662010: 582011: 282012: 16, 4 Class I2013: 642014: 242015: 62016: 102017: 132018: 42019: 132020: 1072021: 12022: 9, 5 Class I2023: 12, 4 Class I2024: 13, 1 Class I2025: 98, 1 Class I2026 (partial year): 10, 2 Class I
2007high 166 (2009) · low 1 (2021)2026

Class I (17 since 2007) Class II/III not classified

Adverse event reports per year · FPA

34,506in 2025

2007: 1,4992008: 1,9412009: 2,5122010: 2,5372011: 4,4072012: 4,9302013: 4,6512014: 4,6952015: 6,6252016: 8,4702017: 6,4622018: 6,5742019: 11,2272020: 9,5632021: 10,4142022: 13,3932023: 10,9162024: 47,2102025: 34,506
2007high 47,210 (2024) · low 1,499 (2007)2025

MAUDE reports naming product code FPA, 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
20071675171,499
20081889151,941
2009101661662,512
201023120582,537
20111287284,407
2012219616 (4)4,930
20131390644,651
20142289244,695
20151712366,625
201612195108,470
201717240136,462
2018417746,574
201971611311,227
2020103271079,563
202113186110,414
2022142139 (5)13,393
20231434012 (4)10,916
2024724413 (1)47,210
20251122598 (1)34,506
2026526610 (2)—

What is it indicated for?

The Contrast Control Device (CCD) is intended for use in the IV delivery of contrast media during imaging procedures with a secondary intended use of conservation of contrast media.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Medex, Inc.

48 FDA decisions under this applicant name. See the company

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  • K040899Medex 3000 Series MR Syringe Infusion PumpMedex, Inc. · 20044 Class I recalls
  • K020780Transtar Intracranial Pressure Transducer, Model MX950ICPMedex, Inc. · 20022 recalls
  • K000328Medex 3000 Series Mri Compatible Syringe Infusion PumpMedex, Inc. · 2000
  • K982640Medex 3000 Series Syringe Infusion PumpMedex, Inc. · 19991 recall

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https://510kreport.com/device/K982123 · printed Nov 4, 2026

Cite this page

510(k) Report. “K982123: Contrast Control Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982123

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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