510(k) Report

510(k) · Cleared

Cleared

Isolate Infusion Cathetr System

K913517510(k) TraditionalCleared Nov 5, 199190-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

Lake Region Mfg., Inc. · DQY Catheter, Percutaneous

Cleared on Nov 5, 1991 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 96 devices in its family, counting itself, have a Class I recall. 95 later devices descend from it.

Decided
Nov 5, 1991
Review
90 days
Class
Class II
Product code
DQY
Recalls
None
Predicates
0

95 later devices descend from it, 6 citing it directly. 2 of the 96 devices in this family, counting this one, have a Class I recall.

Descendants, by year cleared 2003: 4 descendants cleared2004: 6 descendants cleared2009: 1 descendant cleared2002: 3 descendants cleared2006: 9 descendants cleared2008: 9 descendants cleared2014: 2 descendants cleared2005: 10 descendants cleared2007: 7 descendants cleared, 1 with a Class I recall12016: 5 descendants cleared2013: 2 descendants cleared, 1 with a Class I recall12023: 5 descendants cleared2020: 4 descendants cleared2022: 4 descendants cleared2021: 3 descendants cleared2024: 5 descendants cleared2026: 7 descendants cleared2025: 2 descendants cleared2011: 1 descendant cleared2019: 4 descendants cleared2018: 2 descendants cleared1990200020102020
  1. This deviceK913517 Isolate Infusion Cathetr SystemLake Region Mfg., Inc. · 1991
  2. Descendant · cites it directly · 75 of its ownK013635 Trellis Infusion System (10CM Infusion Length); Trellis Infusion…Bacchus Vascular, Inc. · 2002
  3. Descendant · 2 generations on · 57 of its ownK021958 Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion…Bacchus Vascular, Inc. · 2002 · Recalled
  4. Descendant · 2 generations on · 56 of its ownK023514 Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM…Bacchus Vascular, Inc. · 2002 · Recalled
  5. Descendant · 3 generations on · 50 of its ownK030637 Ekos Peripheral Infusion SystemEkos Corp. · 2003
  6. Descendant · 4 generations on · 46 of its ownK033214 Ekos Peripheral Infusion SystemEkos Corp. · 2003

Showing 5 of 95 descendants. See all descendants

Descendants cleared per year

2002: 32003: 42004: 62005: 102006: 92007: 72008: 92009: 12011: 12013: 22014: 22016: 52018: 22019: 42020: 42021: 32022: 42023: 52024: 52025: 22026: 7
2002high 10 (2005) · low 0 (2010)2026

Class I recalls in this family

  • K071664 Trellis-6 Peripheral Infusion System5 generations on · 2007
  • K130904 Trellis-8 Peripheral Infusion System5 generations on · 2013

Most influential descendants

Showing 5 of 95 · See all
  • K013635Trellis Infusion System (10CM Infusion Length); Trellis Infusion System (20CM Infusion…Bacchus Vascular, Inc. · 2002 · cites it directly75descendants
  • K021958Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion Length 20CM (100CM…Bacchus Vascular, Inc. · 2002 · 2 generations on57descendants
  • K023514Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM Infusion Length)Bacchus Vascular, Inc. · 2002 · 2 generations on56descendants
  • K030637Ekos Peripheral Infusion SystemEkos Corp. · 2003 · 3 generations on50descendants
  • K033214Ekos Peripheral Infusion SystemEkos Corp. · 2003 · 4 generations on46descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K913517Isolate Infusion Cathetr SystemLake Region Mfg., Inc.1991—
+1K013635Trellis Infusion System (10CM Infusion Length); Trellis Infusion System (20CM…Bacchus Vascular, Inc.2002—
+2K021958Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion Length 20CM…Bacchus Vascular, Inc.20021
+2K023514Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM Infusion…Bacchus Vascular, Inc.20021
+3K030637Ekos Peripheral Infusion SystemEkos Corp.2003—
+4K033214Ekos Peripheral Infusion SystemEkos Corp.2003—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200230
200340
200460
2005100
200690
200771
200890
200910
201110
201321
201420
201650
201820
201940
202040
202130
202240
202350
202450
202520
202670
FIG. 1 — Lineage of K913517, 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

2 devices in this family have 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
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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? (95)

See all 95

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

NumberDeviceApplicantDecidedDescendants
K013635Trellis Infusion System (10CM Infusion Length); Trellis Infusion System (20CM Infusion…Bacchus Vascular, Inc.200275
K040139Endobionics Microsyringe (Usyringe) Infusion CatheterEndobionics, Inc.20049
K062752Mercator Microsyringe II Infusion CatheterMercator Medsystems, Inc.20068
K023548Proxis Flow-Control Device, Models Eps 101, IC 101Velocimed20036
K041517InfusioncathId, LLC20043
K081147Isoflow Infusion CatheterVascular Designs, Inc.20091

Has anything in its family been recalled? (2 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.

  • K071664Trellis-6 Peripheral Infusion SystemBacchus Vascular, Inc. · 2007 · 5 generations on · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
  • K130904Trellis-8 Peripheral Infusion SystemCovidien · 2013 · 5 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K013635 (Bacchus Vascular, Inc., 2002) has gone furthest, with 75 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 Lake Region Mfg., Inc.

42 FDA decisions under this applicant name. See the company

  • K092965Trailrunner GuidewiresLake Region Mfg., Inc. · 2010
  • K082922Freeway and Railrunner GuidewiresLake Region Mfg., Inc. · 2008
  • K081708Taxi Endoscopic GuidewireLake Region Mfg., Inc. · 2008
  • K080144Mandrel Guidewires or M-WiresLake Region Mfg., Inc. · 2008
  • K073655Pegasus Steerable (Ptca) GuidewireLake Region Mfg., Inc. · 2008

Recent decisions in DQY

The DQY category page

  • K262817CrossFAST Integrated Microcatheter Advanced Delivery SystemVantis Vascular, Inc. · 2026
  • K260559NHanceITIMDS Operation B.V. · 2026
  • K262392APRO 35 Swift CatheterAlembic, LLC · 2026
  • K261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLC · 2026
  • K262240SSPC NXT Delivery CatheterCenterPoint Systems, LLC · 2026

https://510kreport.com/device/K913517 · printed Nov 6, 2026

Cite this page

510(k) Report. “K913517: Isolate Infusion Cathetr System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K913517

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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