510(k) Report

510(k) · Cleared

Cleared

Medrad Disposable Mri Kit W/Check Valve Modelsqk 65V, Medrad Mri Integral T with Check Valve Model Sit 96V

K980417510(k) TraditionalCleared May 4, 199890-day reviewClass II21 CFR 892.1000

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

Medrad, Inc. · LNH System, Nuclear Magnetic Resonance Imaging

Cleared on May 4, 1998 as substantially equivalent to K943189 (Medrad, Inc., 1995) after a 90-day review. Its family tree reaches back 1 generation to 1995.

Decided
May 4, 1998
Review
90 days
Class
Class II
Product code
LNH
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K943189 (1995). No later device cites it as a predicate yet.

Reference device: K800823 · Quick Fill · Medrad, Inc. · 1980K943189 · Medrad Qwik-Fix Mri Disposable Kit · Medrad, Inc. · 1995199619982000
K943189 · Medrad Qwik-Fix Mri Disposable Kit · Medrad, Inc. · 19950
  1. Root · 1 generation backK943189 Medrad Qwik-Fix Mri Disposable KitMedrad, Inc. · 1995
  2. This deviceK980417 Medrad Disposable Mri Kit W/Check Valve Modelsqk 65V, Medrad Mri…Medrad, Inc. · 1998
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K943189Medrad Qwik-Fix Mri Disposable KitMedrad, Inc.1995—
0 (this device)K980417Medrad Disposable Mri Kit W/Check Valve Modelsqk 65V, Medrad Mri Integral T…Medrad, Inc.1998—
FIG. 1 — Lineage of K980417, 1995–1998Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 LNH? 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 LNH device

  1. #1 K213693 MAGNETOM Vida with syngo MR XA50Ascore 23.0 · 18 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K943189Medrad Qwik-Fix Mri Disposable Kit
Summary page 1
…Check Valve . Substantial Equivalence: The Medrad Disposable MRI Kit with Check valve is substantially equivalent to the current Medrad Qwik-Fit MRI Disposables Kit - (K943189). The Medrad Disposable MRI Kit with Check valve has the same ~ intended use as the predicate device - to assist in filling and…
Medrad, Inc.1995—
†K800823Quick FillMedrad, Inc.1980—

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.

How does its category compare?

All LNH devices

LNH System, Nuclear Magnetic Resonance Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LNH

26in 2025

2007: 122008: 192009: 172010: 122011: 162012: 222013: 192014: 172015: 192016: 202017: 182018: 292019: 262020: 322021: 272022: 302023: 302024: 262025: 262026 (partial year): 24
2007high 32 (2020) · low 12 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LNH

122in 2025

2007: 35 days median2008: 53 days median2009: 70 days median2010: 94 days median2011: 81 days median2012: 89 days median2013: 108 days median2014: 108 days median2015: 140 days median2016: 108 days median2017: 98 days median2018: 128 days median2019: 62 days median2020: 121 days median2021: 87 days median2022: 74 days median2023: 124 days median2024: 104 days median2025: 122 days median2026 (partial year): 126 days median
2007high 140 (2015) · low 35 (2007)2026

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

Recalls per year · LNH

8in 2025

2007: 252008: 122009: 72010: 172011: 112012: 52013: 22014: 132015: 12, 2 Class I2016: 12018: 712019: 52020: 42021: 412022: 132023: 10, 1 Class I2024: 42025: 8, 5 Class I2026 (partial year): 43
2007high 71 (2018) · low 0 (2017)2026

Class I (8 since 2007) Class II/III not classified

Adverse event reports per year · LNH

1,263in 2025

2007: 1142008: 1672009: 1942010: 1652011: 1822012: 1702013: 1072014: 1192015: 1132016: 1352017: 1212018: 1582019: 1582020: 982021: 842022: 1382023: 1592024: 2812025: 1,263
2007high 1,263 (2025) · low 84 (2021)2025

MAUDE reports naming product code LNH, 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
2007123525114
2008195312167
200917707194
2010129417165
2011168111182
201222895170
2013191082107
20141710813119
20151914012 (2)113
2016201081135
201718980121
20182912871158
201926625158
202032121498
202127874184
2022307413138
20233012410 (1)159
2024261044281
2025261228 (5)1,263
20262412643—

What is it indicated for?

ThE Medrad Disposable MRI Kit with Check Valve is indicated for use in an MRI environment.

The components of the kit are used to assist in filling and delivering intravascular contrast media and common flushing agents at various volumes and flow rates.

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

More from Medrad, Inc.

105 FDA decisions under this applicant name. See the company

  • K133023Jetstream XC 2.4/3.4; Jetstream XC 2.1/3.0; Jetstream SC 1.85; Jetstream SC 1.6Medrad, Inc. · 20141 recall
  • K130381Angiojet Ultra Power Pulse KitMedrad, Inc. · 2013
  • K130637Jetstream XC 2.4/3.4 System; Jetstream XC 2.1/3.0 System; Jetstream SC 1.85 System; Jetstream SC 1.6 SystemMedrad, Inc. · 2013
  • K122916Jetstream Navitus L System Jeystream Navitus System Jetstream G3 SF System Jetstream SF 1.6 SystemMedrad, Inc. · 2012
  • K113363Angiojet Solent Dista Thrombectomy SetMedrad, Inc. · 20121 recall

Recent decisions in LNH

The LNH category page

  • K262902ECHELON SynergyFujifilm Corporation · 2026
  • K260092Vista AI ScanVista AI, Inc. · 2026
  • K261612SwiftSight-BodyCompositionAirs Medical, Inc. · 2026
  • K261283APERTO Lucent MRI SystemFujifilm Corporation · 2026
  • K261758Embrace Vision Neonatal MRI SystemAspect Imaging, Ltd. · 2026

https://510kreport.com/device/K980417 · printed Nov 6, 2026

Cite this page

510(k) Report. “K980417: Medrad Disposable Mri Kit W/Check Valve Modelsqk 65V, Medrad Mri Integral T with Check Valve Model Sit 96V.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980417

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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