510(k) Report

510(k) · Cleared

Cleared

Pta and PTV

K022722510(k) SpecialCleared Sep 13, 200228-day reviewClass II21 CFR 870.1250

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

NuMED, Inc. · DQY Catheter, Percutaneous

Cleared on Sep 13, 2002 after a 28-day review. The FDA summary names its predicate without a number. 10 later devices descend from it.

Decided
Sep 13, 2002
Review
28 days
Class
Class II
Product code
DQY
Recalls
None
Predicates
0

10 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2010: 1 descendant cleared2004: 1 descendant cleared2008: 1 descendant cleared2016: 1 descendant cleared2012: 1 descendant cleared2013: 1 descendant cleared2022: 1 descendant cleared2014: 1 descendant cleared2024: 1 descendant cleared2025: 1 descendant cleared200020052010201520202025
  1. This deviceK022722 Pta and PTVNuMED, Inc. · 2002
  2. Descendant · cites it directly · 6 of its ownK102473 Mullins-X PTV CatheterNuMED, Inc. · 2010
  3. Descendant · 2 generations on · 5 of its ownK122367 Bard PTV Dilatation CatheterC.R. Bard, Inc. · 2012
  4. Descendant · 3 generations on · 4 of its ownK131002 Vida PTV Dilataton CatheterC.R. Bard, Inc. · 2013
  5. Descendant · 4 generations on · 3 of its ownK141985 True BA V Balloon Valvuloplasty CatheterC.R. Bard, Inc. · 2014
  6. Descendant · 4 generations on · 2 of its ownK212588 Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation…C.R. Bard, Inc. · 2022

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2004: 12008: 12010: 12012: 12013: 12014: 12016: 12022: 12024: 12025: 1
2004high 1 (2004) · low 0 (2005)2026

Most influential descendants

Showing 5 of 10 · See all
  • K102473Mullins-X PTV CatheterNuMED, Inc. · 2010 · cites it directly6descendants
  • K122367Bard PTV Dilatation CatheterC.R. Bard, Inc. · 2012 · 2 generations on5descendants
  • K131002Vida PTV Dilataton CatheterC.R. Bard, Inc. · 2013 · 3 generations on4descendants
  • K141985True BA V Balloon Valvuloplasty CatheterC.R. Bard, Inc. · 2014 · 4 generations on3descendants
  • K212588Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida PTV…C.R. Bard, Inc. · 2022 · 4 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K022722Pta and PTVNuMED, Inc.2002—
+1K102473Mullins-X PTV CatheterNuMED, Inc.2010—
+2K122367Bard PTV Dilatation CatheterC.R. Bard, Inc.2012—
+3K131002Vida PTV Dilataton CatheterC.R. Bard, Inc.2013—
+4K141985True BA V Balloon Valvuloplasty CatheterC.R. Bard, Inc.2014—
+4K212588Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida…C.R. Bard, Inc.2022—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200810
201010
201210
201310
201410
201610
202210
202410
202510
FIG. 1 — Lineage of K022722, 2002–2025Source: 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 DQY? 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 DQY device

  1. #1 K234115 APRO 55 Catheterscore 17.5 · 6 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? (5)

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
*—Tyshak
Named without a submission number
—
*—Tyshak II
Named without a submission number
—
*—Z-MED
Named without a submission number
—
*—Z-Med II
Named without a submission number
—
*—Mullins
Named without a submission number
—

What descends from it? (10)

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

NumberDeviceApplicantDecidedDescendants
K102473Mullins-X PTV CatheterNuMED, Inc.20106
K040830Pta, PTV, Atrioseptostomy, Angiographic, Sizing CathetersNuMED, Inc.20041
K081680Nucleus-X, Model 230XNuMED, Inc.20080

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, K102473 (NuMED, Inc., 2010) has gone furthest, with 6 descendants of its own.

How does its category compare?

All DQY devices

DQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQY

21in 2025

2007: 162008: 312009: 372010: 222011: 362012: 302013: 322014: 192015: 272016: 222017: 262018: 252019: 302020: 202021: 182022: 182023: 182024: 162025: 212026 (partial year): 11
2007high 37 (2009) · low 16 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQY

115in 2025

2007: 85 days median2008: 66 days median2009: 73 days median2010: 74 days median2011: 71 days median2012: 87 days median2013: 92 days median2014: 127 days median2015: 118 days median2016: 117 days median2017: 113 days median2018: 106 days median2019: 111 days median2020: 120 days median2021: 81 days median2022: 74 days median2023: 114 days median2024: 87 days median2025: 115 days median2026 (partial year): 30 days median
2007high 127 (2014) · low 66 (2008)2026

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

Recalls per year · DQY

1in 2025

2007: 62008: 122009: 172010: 322011: 62012: 22013: 36, 1 Class I2014: 32015: 32016: 22, 7 Class I2017: 82018: 22019: 12020: 22021: 22023: 172024: 12025: 1, 1 Class I2026 (partial year): 2, 1 Class I
2007high 36 (2013) · low 0 (2022)2026

Class I (10 since 2007) Class II/III not classified

Adverse event reports per year · DQY

3,056in 2025

2007: 3132008: 4962009: 8192010: 1,2932011: 1,2112012: 1,1912013: 1,3522014: 1,4972015: 2,3372016: 2,2522017: 2,4892018: 2,8552019: 2,9022020: 2,8892021: 3,0062022: 2,6432023: 3,0492024: 3,1902025: 3,056
2007high 3,190 (2024) · low 313 (2007)2025

MAUDE reports naming product code DQY, 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
200716856313
2008316612496
2009377317819
20102274321,293
2011367161,211
2012308721,191
2013329236 (1)1,352
20141912731,497
20152711832,337
20162211722 (7)2,252
20172611382,489
20182510622,855
20193011112,902
20202012022,889
2021188123,006
2022187402,643
202318114173,049
2024168713,190
2025211151 (1)3,056
202611302 (1)—

What is it indicated for?

Z-MED-X Catheter - This catheter is recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve. A patient with isolated pulmonary stenosis A patient with valvular pulmonary stenosis with other minor congenital heart disease that does not require surgical intervention. And; This catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, iliac, and renal arteries. These catheters are not designed to be…

Read the full statement (252 words)

Z-MED-X Catheter - This catheter is recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve.

A patient with isolated pulmonary stenosis

A patient with valvular pulmonary stenosis with other minor congenital heart disease that does not require surgical intervention. And;

This catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, iliac, and renal arteries. These catheters are not designed to be used in the coronary arteries.

Tyshak-X Catheter - This catheter is recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve.

A patient with isolated pulmonary stenosis

A patient with valvular pulmonary stenosis with other minor congenital heart disease that does not require surgical intervention. And;

This catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, iliac, and renal arteries. These catheters are not designed to be used in the coronary arteries.

Tyshak 11-X Catheter - This catheter is recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve.

A patient with isolated pulmonary stenosis

A patient with valvular pulmonary stenosis with other minor congenital heart disease that does not require surgical intervention. And;

Z-MED 11-XCatheter - This catheter is recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve.

A patient with isolated pulmonary stenosis

A patient with valvular pulmonary stenosis with other minor congenital heart disease that does not require surgical intervention. And;

Mullins-X PTA - This catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, iliac, and renal arteries. These catheters are not designed to be used in the coronary arteries.

Indications for use as stated in the FDA summary.

More from NuMED, Inc.

57 FDA decisions under this applicant name. See the company

  • P150028/S007CP Stent (Model 425), Covered CP Stent (Model 427), Mounted CP Stent (Model 426), Covered and Mounted CP…NuMED, Inc. · 2026
  • K213915BIB Stent Placement CatheterNuMED, Inc. · 2022
  • P150028/S006G-Armor Stent, G-Armor Covered Stent, G-Armor Mounted Stent, G-Armor Covered Mounted StentNuMED, Inc. · 2021
  • P150028/S005NuDEL Delivery SystemNuMED, Inc. · 2021
  • K211910Z-6 Atrioseptostomy CatheterNuMED, Inc. · 2021

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The DQY category page

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https://510kreport.com/device/K022722 · printed Nov 6, 2026

Cite this page

510(k) Report. “K022722: Pta and PTV.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022722

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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