510(k) Report

510(k) · Cleared

Cleared

Fox Pta Catheter, 3.0, 4.0, 5.0, 6.0, 7.0, and 8.0 X 40 MM, Models A14003, A14004, A14005, A14006, A14007, A14008

K010838510(k) TraditionalCleared Jun 21, 200193-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

Jomed AG · DQY Catheter, Percutaneous

Cleared on Jun 21, 2001 after a 93-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 17 later devices descend from it.

Decided
Jun 21, 2001
Review
93 days
Class
Class II
Product code
DQY
Recalls
None
Predicates
0

17 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2003: 1 descendant cleared2002: 1 descendant cleared2004: 1 descendant cleared2006: 2 descendants cleared2008: 3 descendants cleared2007: 2 descendants cleared2005: 1 descendant cleared2015: 2 descendants cleared2014: 1 descendant cleared2013: 1 descendant cleared2023: 1 descendant cleared2025: 1 descendant cleared200020052010201520202025
  1. This deviceK010838 Fox Pta Catheter, 3.0, 4.0, 5.0, 6.0, 7.0, and 8.0 X 40 MM, Models…Jomed AG · 2001
  2. Descendant · cites it directly · 16 of its ownK020854 Modification to Fox Pta CatheterJomed AG · 2002
  3. Descendant · cites it directly · 8 of its ownK033217 Pheron Pta CatheterBiotronik, Inc. · 2003
  4. Descendant · 2 generations on · 7 of its ownK072765 Passeo 18Biotronik, Inc. · 2007
  5. Descendant · 2 generations on · 5 of its ownK082933 Passeo-35 Pta CatheterBiotronik, Inc. · 2008
  6. Descendant · 2 generations on · 5 of its ownK040954 Fox Plus Pta CatheterAbbott Laboratories, Inc. · 2004

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

2002: 12003: 12004: 12005: 12006: 22007: 22008: 32013: 12014: 12015: 22023: 12025: 1
2002high 3 (2008) · low 0 (2009)2026

Most influential descendants

Showing 5 of 17 · See all
  • K020854Modification to Fox Pta CatheterJomed AG · 2002 · cites it directly16descendants
  • K033217Pheron Pta CatheterBiotronik, Inc. · 2003 · cites it directly8descendants
  • K072765Passeo 18Biotronik, Inc. · 2007 · 2 generations on7descendants
  • K082933Passeo-35 Pta CatheterBiotronik, Inc. · 2008 · 2 generations on5descendants
  • K040954Fox Plus Pta CatheterAbbott Laboratories, Inc. · 2004 · 2 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K010838Fox Pta Catheter, 3.0, 4.0, 5.0, 6.0, 7.0, and 8.0 X 40 MM, Models A14003…Jomed AG2001—
+1K020854Modification to Fox Pta CatheterJomed AG2002—
+1K033217Pheron Pta CatheterBiotronik, Inc.2003—
+2K072765Passeo 18Biotronik, Inc.2007—
+2K082933Passeo-35 Pta CatheterBiotronik, Inc.2008—
+2K040954Fox Plus Pta CatheterAbbott Laboratories, Inc.2004—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200310
200410
200510
200620
200720
200830
201310
201410
201520
202310
202510
FIG. 1 — Lineage of K010838, 2001–2025Source: 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), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (17)

See all 17

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

NumberDeviceApplicantDecidedDescendants
K020854Modification to Fox Pta CatheterJomed AG200216
K033217Pheron Pta CatheterBiotronik, Inc.20038

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, K020854 (Jomed AG, 2002) has gone furthest, with 16 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)—

More from Jomed AG

3 FDA decisions under this applicant name. See the company

  • K030053Jostent Selfx, Models 015SX4406; 015SX4408; 015SX4410; 015SX680; 015SX6808; 015SX6810Jomed AG · 2003
  • K020854Modification to Fox Pta CatheterJomed AG · 2002

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The DQY category page

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https://510kreport.com/device/K010838 · printed Nov 4, 2026

Cite this page

510(k) Report. “K010838: Fox Pta Catheter, 3.0, 4.0, 5.0, 6.0, 7.0, and 8.0 X 40 MM, Models A14003, A14004, A14005, A14006, A14007, A14008.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K010838

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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