510(k) Report

510(k) · Cleared

Recalled · 2010

Merit Custom Kit

K913682510(k) TraditionalCleared Nov 15, 199188-day reviewClass II21 CFR 870.1200Recalls 19

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. · DQO Catheter, Intravascular, Diagnostic

Cleared on Nov 15, 1991 after an 88-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it. It has been recalled 19 times.

Decided
Nov 15, 1991
Review
88 days
Class
Class II
Product code
DQO
Recalls
19
Predicates
0

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

Descendants, by year cleared 2016: 1 descendant cleared1990200020102020
  1. This deviceK913682 Merit Custom KitMerit Medical Systems, Inc. · 1991
  2. Descendant · cites it directly · 0 of its ownK152978 DeRoyal Angiography KitsDeroyal Industries, Inc. · 2016

Most influential descendants

Showing 1 of 1 · See all
  • K152978DeRoyal Angiography KitsDeroyal Industries, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K913682Merit Custom KitMerit Medical Systems, Inc.1991—
+1K152978DeRoyal Angiography KitsDeroyal Industries, Inc.2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201610
FIG. 1 — Lineage of K913682, 1991–2016Source: 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.

Planning a device in DQO? 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 DQO device

  1. #1 K254278 Arterial Pressure Monitoring Set/Trayscore 14.4 · 2 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?

FDA lists a 510(k) statement for it but has not posted the file, 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
K152978DeRoyal Angiography KitsDeroyal Industries, Inc.20160

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Oct 25, 2010Not classifiedZ-0557-2011Process controlDefective custom kits may draw in air during use which may compromise patient safety and affect treatment. The valve's fixed luer may be over- or under-tightened, causing leaking at the bond joint.
Oct 25, 2010Not classifiedZ-0558-2011Process controlDefective custom kits may draw in air during use which may compromise patient safety and affect treatment. The valve's fixed luer may be over- or under-tightened, causing leaking at the bond joint.
Oct 25, 2010Not classifiedZ-0559-2011Process controlDefective custom kits may draw in air during use which may compromise patient safety and affect treatment. The valve's fixed luer may be over- or under-tightened, causing leaking at the bond joint.
Oct 25, 2010Not classifiedZ-0552-2011Process controlDefective custom kits may draw in air during use which may compromise patient safety and affect treatment. The valve's fixed luer may be over- or under-tightened, causing leaking at the bond joint.
Oct 25, 2010Not classifiedZ-0553-2011Process controlDefective custom kits may draw in air during use which may compromise patient safety and affect treatment. The valve's fixed luer may be over- or under-tightened, causing leaking at the bond joint.
Oct 25, 2010Not classifiedZ-0554-2011Process controlDefective custom kits may draw in air during use which may compromise patient safety and affect treatment. The valve's fixed luer may be over- or under-tightened, causing leaking at the bond joint.
Oct 25, 2010Not classifiedZ-0555-2011Process controlDefective custom kits may draw in air during use which may compromise patient safety and affect treatment. The valve's fixed luer may be over- or under-tightened, causing leaking at the bond joint.
Oct 25, 2010Not classifiedZ-0556-2011Process controlDefective custom kits may draw in air during use which may compromise patient safety and affect treatment. The valve's fixed luer may be over- or under-tightened, causing leaking at the bond joint.
Sep 29, 2009Not classifiedZ-0510-2010OtherPotential sterility breach caused by excessive shipment damage.
Sep 29, 2009Not classifiedZ-0511-2010OtherPotential sterility breach caused by excessive shipment damage.
Sep 12, 2008Not classifiedZ-0578-2009Process controlLeak, disposal bag: A Merit Disposal Depot (MDD) bag contained in certain custom waste management kits may leak. For further information, please contact Merit Medical Systems, Inc. by telephone at 801-208-4748.
Sep 2, 2005Not classifiedZ-0080-06OtherComponent of procedure kits may allow higher than desired amount of IV solution to be infused in to patient during pressure monitoring procedure.
Sep 2, 2005Not classifiedZ-0077-06OtherComponent of procedure kits may allow higher than desired amount of IV solution to be infused in to patient during pressure monitoring procedure.
Sep 2, 2005Not classifiedZ-0079-06OtherComponent of procedure kits may allow higher than desired amount of IV solution to be infused in to patient during pressure monitoring procedure.
Sep 2, 2005Not classifiedZ-0078-06OtherComponent of procedure kits may allow higher than desired amount of IV solution to be infused in to patient during pressure monitoring procedure.
Sep 2, 2005Not classifiedZ-0081-06OtherComponent of procedure kits may allow higher than desired amount of IV solution to be infused in to patient during pressure monitoring procedure.
Feb 13, 2003Not classifiedZ-0620-03OtherA recent design change feature in the cap closure design for stopcocks in tubing convenience kits could preclude proper sterilization.
Feb 13, 2003Not classifiedZ-0621-03OtherA recent design change feature in the cap closure design for stopcocks in tubing convenience kits could preclude proper sterilization.
Feb 13, 2003Not classifiedZ-0622-03OtherA recent design change feature in the cap closure design for stopcocks in tubing convenience kits could preclude proper sterilization.

The 5 latest of 19 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K152978 (Deroyal Industries, Inc., 2016) has gone furthest, with 0 descendants of its own.

How does its category compare?

All DQO devices

DQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQO

2in 2025

2007: 82008: 32009: 82010: 72011: 62012: 152013: 22014: 32015: 102016: 42017: 102018: 102019: 62020: 32021: 12022: 42023: 42024: 42025: 22026 (partial year): 3
2007high 15 (2012) · low 1 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQO

148in 2024

2007: 106 days median2008: 80 days median2009: 58 days median2010: 137 days median2011: 74 days median2012: 94 days median2014: 109 days median2015: 209 days median2016: 89 days median2017: 176 days median2018: 234 days median2019: 113 days median2020: 30 days median2022: 181 days median2023: 73 days median2024: 148 days median2026 (partial year): 85 days median
2007high 234 (2018) · low 30 (2020)2026

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

Recalls per year · DQO

1in 2023

2007: 142008: 42009: 72010: 112011: 72012: 22013: 12015: 1, 1 Class I2016: 2, 1 Class I2017: 12018: 22019: 712020: 4, 4 Class I2022: 12023: 1, 1 Class I2026 (partial year): 24, 4 Class I
2007high 71 (2019) · low 0 (2014)2026

Class I (11 since 2007) Class II/III not classified

Adverse event reports per year · DQO

656in 2025

2007: 5642008: 7262009: 9332010: 5562011: 6252012: 5322013: 7532014: 6012015: 6282016: 6142017: 8732018: 7772019: 3862020: 3122021: 3382022: 3792023: 3912024: 5112025: 656
2007high 933 (2009) · low 312 (2020)2025

MAUDE reports naming product code DQO, 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
2007810614564
20083804726
20098587933
2010713711556
20116747625
201215942532
20132—1753
201431090601
2015102091 (1)628
20164892 (1)614
2017101761873
2018102342777
2019611371386
20203304 (4)312
20211—0338
202241811379
20234731 (1)391
202441480511
20252—0656
202638524 (4)—

More from Merit Medical Systems, Inc.

185 FDA decisions under this applicant name. See the company

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Recent decisions in DQO

The DQO category page

  • K261455Arterial Pressure Monitoring Set/TraySpectrum Vascular · 2026
  • K252702Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF…Bioptimal International Pte., Ltd. · 2026
  • K254278Arterial Pressure Monitoring Set/TraySpectrum Vascular · 2026
  • K250751DualView CatheterTerumo Corporation · 2025
  • K242966Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging CatheterGentuity, LLC · 20251 recall

https://510kreport.com/device/K913682 · printed Nov 4, 2026

Cite this page

510(k) Report. “K913682: Merit Custom Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K913682

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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