510(k) Report

510(k) · Cleared

Cleared

Fluid Administration Set - Contrast Manager

K961794510(k) TraditionalCleared Aug 1, 199684-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

Merit Medical Systems, Inc. · FPA Set, Administration, Intravascular

Cleared on Aug 1, 1996 as substantially equivalent to K903493 (North American Instrument Corp., 1991) after an 84-day review. Its family tree reaches back 1 generation to 1991. 39 later devices descend from it.

Decided
Aug 1, 1996
Review
84 days
Class
Class II
Product code
FPA
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K903493 (1991). 39 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2002: 1 descendant cleared2008: 2 descendants cleared2005: 3 descendants cleared2007: 1 descendant cleared2000: 1 descendant cleared2004: 1 descendant cleared2003: 1 descendant cleared2010: 2 descendants cleared2025: 1 descendant cleared2011: 1 descendant cleared2018: 4 descendants cleared2015: 5 descendants cleared2013: 1 descendant cleared2019: 3 descendants cleared2026: 2 descendants cleared2014: 1 descendant cleared2017: 4 descendants cleared2022: 1 descendant cleared2021: 1 descendant cleared2020: 1 descendant cleared2016: 2 descendants clearedK903493 · Namic Contrast Savings Delivery System · North American Instrument Corp. · 19911990200020102020
Descendants, by generation 1 generation forward: 6 descendants2 generations forward: 9 descendants3 generations forward: 5 descendants4 generations forward: 6 descendants5 generations forward: 5 descendants6 generations forward: 1 descendant7 generations forward: 1 descendant8 generations forward: 3 descendants9 generations forward: 3 descendants K903493 · Namic Contrast Savings Delivery System · North American Instrument Corp. · 19910+5
  1. Root · 1 generation backK903493 Namic Contrast Savings Delivery SystemNorth American Instrument Corp. · 1991
  2. This deviceK961794 Fluid Administration Set - Contrast ManagerMerit Medical Systems, Inc. · 1996
  3. Descendant · cites it directly · 20 of its ownK984231 Angiographic Contrast Management System, Model Part a and Part BInvasatec · 2000 · Recalled
  4. Descendant · cites it directly · 15 of its ownK022431 Medrad Transfer SetMedrad, Inc. · 2002
  5. Descendant · 2 generations on · 14 of its ownK052744 C2000 Automated Manifold KitAcist Medical Systems, Inc. · 2005 · Recalled
  6. Descendant · 3 generations on · 13 of its ownK131478 Contrast Conservation SystemOsprey Medical, Inc. · 2013
  7. Descendant · 4 generations on · 12 of its ownK140425 Contrast Modulation SystemOsprey Medical, Inc. · 2014

Showing 5 of 39 descendants. See all descendants

Descendants cleared per year

2000: 12002: 12003: 12004: 12005: 32007: 12008: 22010: 22011: 12013: 12014: 12015: 52016: 22017: 42018: 42019: 32020: 12021: 12022: 12025: 12026: 2
2000high 5 (2015) · low 0 (2001)2026

Most influential descendants

Showing 5 of 39 · See all
  • K984231Angiographic Contrast Management System, Model Part a and Part BInvasatec · 2000 · cites it directly20descendants
  • K022431Medrad Transfer SetMedrad, Inc. · 2002 · cites it directly15descendants
  • K052744C2000 Automated Manifold KitAcist Medical Systems, Inc. · 2005 · 2 generations on14descendants
  • K131478Contrast Conservation SystemOsprey Medical, Inc. · 2013 · 3 generations on13descendants
  • K140425Contrast Modulation SystemOsprey Medical, Inc. · 2014 · 4 generations on12descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K903493Namic Contrast Savings Delivery SystemNorth American Instrument Corp.1991—
0 (this device)K961794Fluid Administration Set - Contrast ManagerMerit Medical Systems, Inc.1996—
+1K984231Angiographic Contrast Management System, Model Part a and Part BInvasatec20004
+1K022431Medrad Transfer SetMedrad, Inc.2002—
+2K052744C2000 Automated Manifold KitAcist Medical Systems, Inc.20051
+3K131478Contrast Conservation SystemOsprey Medical, Inc.2013—
+4K140425Contrast Modulation SystemOsprey Medical, Inc.2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200010
200210
200310
200410
200530
200710
200820
201020
201110
201310
201410
201550
201620
201740
201840
201930
202010
202110
202210
202510
202620
FIG. 1 — Lineage of K961794, 1991–2026Source: 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.

Top candidate predicates for a new FPA device

  1. #1 K243841 Sparta Infusion Set for Insulinscore 13.4 · 3 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
*K903493Namic Contrast Savings Delivery System
Summary page 1
…cate device is the "contrast savings delivery system” manufactured by North American Instrument Company (NAMIC®) and reviewed by FDA under premarket notification number K903493. ) DEVICE DESCRIPTION The device consists of two parts; the spike assembly and the Miser™ fluid administration set. The spike…
North American Instrument Corp.1991—

Also cleared against K903493: 4 other devices →

What descends from it? (39)

See all 39

6 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K984231Angiographic Contrast Management System, Model Part a and Part BInvasatec200020
K022431Medrad Transfer SetMedrad, Inc.200215
K040456Fleboset MultipleLaboratorios Grifols, S.A.200411
K083576Miser Contrast Management SystemMerit Medical Systems, Inc.20080
K063114Disposable Transfer Sets with and Without Swabbable Valves and/or Check ValvesCoeur, Inc.20070
K052252Contrast Media Transfer SetsB.Braun Medical, Inc.20050

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.
  • Of its descendants, K984231 (Invasatec, 2000) has gone furthest, with 20 descendants of its own.
  • 4 other devices also cite its predicate K903493.

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)—

Also cleared against K903493

4 other devices cite the same predicate.

  • K052252Contrast Media Transfer SetsB.Braun Medical, Inc. · 2005
  • K984231Angiographic Contrast Management System, Model Part a and Part BInvasatec · 20004 recalls
  • K982123Contrast Control DeviceMedex, Inc. · 1998
  • K955179Contrast Media SetB.Braun Medical, Inc. · 1997

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The FPA category page

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https://510kreport.com/device/K961794 · printed Nov 4, 2026

Cite this page

510(k) Report. “K961794: Fluid Administration Set - Contrast Manager.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961794

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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