510(k) Report

510(k) · Cleared

Cleared

Ilt 0.014 Catheter, Model C114NL2

K001992510(k) TraditionalCleared Sep 25, 200088-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

Intra Luminal Therapeutics, Inc. · DQY Catheter, Percutaneous

Cleared on Sep 25, 2000 after an 88-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 159 devices in its family, counting itself, has a Class I recall. 158 later devices descend from it.

Decided
Sep 25, 2000
Review
88 days
Class
Class II
Product code
DQY
Recalls
None
Predicates
0

158 later devices descend from it, 5 citing it directly. 1 of the 159 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2002: 2 descendants cleared2001: 1 descendant cleared2003: 4 descendants cleared2008: 2 descendants cleared2009: 11 descendants cleared2005: 3 descendants cleared2006: 2 descendants cleared2012: 19 descendants cleared2007: 2 descendants cleared2014: 6 descendants cleared, 1 with a Class I recall12010: 6 descendants cleared2011: 7 descendants cleared2015: 9 descendants cleared2013: 4 descendants cleared2017: 12 descendants cleared2021: 9 descendants cleared2018: 8 descendants cleared2016: 14 descendants cleared2020: 9 descendants cleared2022: 7 descendants cleared2019: 5 descendants cleared2023: 5 descendants cleared2026: 3 descendants cleared2024: 3 descendants cleared2025: 5 descendants cleared200020052010201520202025
  1. This deviceK001992 Ilt 0.014 Catheter, Model C114NL2Intra Luminal Therapeutics, Inc. · 2000
  2. Descendant · cites it directly · 123 of its ownK012169 Ilt Support Catheter .014, Model C114LW1; Ilt Support Catheter…Intra Luminal Therapeutics, Inc. · 2001
  3. Descendant · 2 generations on · 122 of its ownK030984 Safe Cross Angled Support 0.14, Safe Cross Straight Support Catheter…Intra Luminal Therapeutics, Inc. · 2003
  4. Descendant · 3 generations on · 120 of its ownK032660 Xtrak Support CatheterXtrak Medical, Inc. · 2003
  5. Descendant · 2 generations on · 119 of its ownK051772 Asahi Tornus Support CatheterAsahi Intecc Co., Ltd. · 2005
  6. Descendant · cites it directly · 105 of its ownK011562 Lumend Percutaneous CatheterLumend, Inc. · 2002

Showing 5 of 158 descendants. See all descendants

Descendants cleared per year

2001: 12002: 22003: 42005: 32006: 22007: 22008: 22009: 112010: 62011: 72012: 192013: 42014: 62015: 92016: 142017: 122018: 82019: 52020: 92021: 92022: 72023: 52024: 32025: 52026: 3
2001high 19 (2012) · low 0 (2004)2026

Class I recalls in this family

  • K141547 Wingman Extendable Tip Support Catheter8 generations on · 2014

Most influential descendants

Showing 5 of 158 · See all
  • K012169Ilt Support Catheter .014, Model C114LW1; Ilt Support Catheter Advancing Mechanism…Intra Luminal Therapeutics, Inc. · 2001 · cites it directly123descendants
  • K030984Safe Cross Angled Support 0.14, Safe Cross Straight Support Catheter 0.14, Safe Cross…Intra Luminal Therapeutics, Inc. · 2003 · 2 generations on122descendants
  • K032660Xtrak Support CatheterXtrak Medical, Inc. · 2003 · 3 generations on120descendants
  • K051772Asahi Tornus Support CatheterAsahi Intecc Co., Ltd. · 2005 · 2 generations on119descendants
  • K011562Lumend Percutaneous CatheterLumend, Inc. · 2002 · cites it directly105descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K001992Ilt 0.014 Catheter, Model C114NL2Intra Luminal Therapeutics, Inc.2000—
+1K012169Ilt Support Catheter .014, Model C114LW1; Ilt Support Catheter Advancing…Intra Luminal Therapeutics, Inc.2001—
+2K030984Safe Cross Angled Support 0.14, Safe Cross Straight Support Catheter 0.14…Intra Luminal Therapeutics, Inc.2003—
+3K032660Xtrak Support CatheterXtrak Medical, Inc.2003—
+2K051772Asahi Tornus Support CatheterAsahi Intecc Co., Ltd.2005—
+1K011562Lumend Percutaneous CatheterLumend, Inc.2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200220
200340
200530
200620
200720
200820
2009110
201060
201170
2012190
201340
201461
201590
2016140
2017120
201880
201950
202090
202190
202270
202350
202430
202550
202630
FIG. 1 — Lineage of K001992, 2000–2026Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

1 device in this family has a Class I recall. 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? (158)

See all 158

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

NumberDeviceApplicantDecidedDescendants
K012169Ilt Support Catheter .014, Model C114LW1; Ilt Support Catheter Advancing Mechanism…Intra Luminal Therapeutics, Inc.2001123
K011562Lumend Percutaneous CatheterLumend, Inc.2002105
K082339Enabler-P Support CatheterEndocross, Ltd.200814
K021802Stereotaxis Catheter Advancer SystemStereotaxis, Inc.20032
K021638Ilt Advancing Mechanism, Model A115AMIIntra Luminal Therapeutics, Inc.20020

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K141547Wingman Extendable Tip Support CatheterReflow Medical · 2014 · 8 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K012169 (Intra Luminal Therapeutics, Inc., 2001) has gone furthest, with 123 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 Intra Luminal Therapeutics, Inc.

20 FDA decisions under this applicant name. See the company

  • K050916Safe-Cross Radio Frequency Total Occlusion Crossing System [Peripheral]Intra Luminal Therapeutics, Inc. · 2005
  • K050915Safe-Cross Radio Frequency Total Occlusion Crossing System [Coronary]Intra Luminal Therapeutics, Inc. · 2005
  • K041973Modification to Safe-Cross Radio Frequency Total Occlusion Crossing SystemIntra Luminal Therapeutics, Inc. · 2004
  • K040481Safe-Cross Deflecting Catheter, Model C118ND1Intra Luminal Therapeutics, Inc. · 2004
  • K040037Modification to Safe-Cross Radio Frequency Total Occlusion Crossing SystemIntra Luminal Therapeutics, Inc. · 2004

Recent decisions in DQY

The DQY category page

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https://510kreport.com/device/K001992 · printed Nov 6, 2026

Cite this page

510(k) Report. “K001992: Ilt 0.014 Catheter, Model C114NL2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001992

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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