510(k) Report

510(k) · Cleared

Recalled · Class II · 2018

Long Sheath or LS, 70 CM, Long Sheath or LS, 80 CM, Long Sheath or LS, 90 CM

K152876510(k) TraditionalCleared Jan 8, 2016100-day reviewClass II21 CFR 870.1250Recalls 1

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

Tni Manufacturing, Inc. · DQY Catheter, Percutaneous

Cleared on Jan 8, 2016 as substantially equivalent to K111380 (Penumbra, Inc., 2011) after a 100-day review. Its family tree reaches back 6 generations to 2001. 1 of the 22 devices in its family, counting itself, has a Class I recall. 13 later devices descend from it. It has been recalled once.

Decided
Jan 8, 2016
Review
100 days
Class
Class II
Product code
DQY
Recalls
1
Predicates
1

Its longest line of descent runs back 6 generations to K010954 (2001). 8 ancestors in all, the oldest K010853 (2001). 13 later devices descend from it, 3 citing it directly. 1 of the 22 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2008: 1 other ancestor2001: 1 other ancestor2019: 2 descendants cleared2017: 1 descendant cleared2020: 1 descendant cleared2023: 1 descendant cleared2021: 1 descendant cleared2025: 2 descendants cleared2024: 3 descendants cleared, 1 with a Class I recall12026: 2 descendants clearedK010954 · Concentric Balloon Guide Catheter, Model 90031 · Concentric Medical, Inc. · 2001 · recalledK021899 · Concentric Balloon Guide Catheter, Model 90072 · Concentric Medical, Inc. · 2002 · recalledK053491 · Penumbra Balloon Guide Catheter, Model 7.5F · Penumbra, Inc. · 2006K070970 · Neuron Support Catheter System, Model 5F/6F · Penumbra, Inc. · 2007 · recalledK082290 · Neuron Delivery Catheter 070 · Penumbra, Inc. · 2008 · recalledK111380 · Neuron Max System · Penumbra, Inc. · 2011200020052010201520202025
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor3 generations back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 6 descendants, 1 with a Class I recall13 generations forward: 4 descendants K111380 · Neuron Max System · Penumbra, Inc. · 2011K082290 · Neuron Delivery Catheter 070 · Penumbra, Inc. · 2008 · recalledK070970 · Neuron Support Catheter System, Model 5F/6F · Penumbra, Inc. · 2007 · recalledK053491 · Penumbra Balloon Guide Catheter, Model 7.5F · Penumbra, Inc. · 2006K021899 · Concentric Balloon Guide Catheter, Model 90072 · Concentric Medical, Inc. · 2002 · recalledK010954 · Concentric Balloon Guide Catheter, Model 90031 · Concentric Medical, Inc. · 2001 · recalled−50
  1. Root · 6 generations backK010954 Concentric Balloon Guide Catheter, Model 90031Concentric Medical, Inc. · 2001 · Recalled
  2. 5 generations backK021899 Concentric Balloon Guide Catheter, Model 90072Concentric Medical, Inc. · 2002 · Recalled
  3. 4 generations backK053491 Penumbra Balloon Guide Catheter, Model 7.5FPenumbra, Inc. · 2006
  4. 3 generations backK070970 Neuron Support Catheter System, Model 5F/6FPenumbra, Inc. · 2007 · Recalled
  5. 2 generations backK082290 Neuron Delivery Catheter 070Penumbra, Inc. · 2008 · Recalled
  6. 1 generation backK111380 Neuron Max SystemPenumbra, Inc. · 2011
  7. This deviceK152876 Long Sheath or LS, 70 CM, Long Sheath or LS, 80 CM, Long Sheath or…Tni Manufacturing, Inc. · 2016
  8. Descendant · cites it directly · 6 of its ownK191551 RIST Cath Radial Access Long SheathRist Neurovascular, Inc. · 2019
  9. Descendant · 2 generations on · 2 of its ownK231393 Radical the Dude 7F Guide CatheterMaduro Medical, Inc. · 2023
  10. Descendant · 2 generations on · 2 of its ownK211990 Rist 071 Radial Access Guide CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2021
  11. Descendant · cites it directly · 2 of its ownK191717 Route 92 Medical Sheath SystemRoute 92 Medical, Inc. · 2020
  12. Descendant · cites it directly · 2 of its ownK172468 091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cmInneuroco, Inc. · 2017 · Recalled

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2017: 12019: 22020: 12021: 12023: 12024: 32025: 22026: 2
2017high 3 (2024) · low 0 (2018)2026

Class I recalls in this family

  • K242376 Next Generation Access Platform2 generations on · 2024

Most influential descendants

Showing 5 of 13 · See all
  • K191551RIST Cath Radial Access Long SheathRist Neurovascular, Inc. · 2019 · cites it directly6descendants
  • K231393Radical the Dude 7F Guide CatheterMaduro Medical, Inc. · 2023 · 2 generations on2descendants
  • K211990Rist 071 Radial Access Guide CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2021 · 2 generations on2descendants
  • K191717Route 92 Medical Sheath SystemRoute 92 Medical, Inc. · 2020 · cites it directly2descendants
  • K172468091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cmInneuroco, Inc. · 2017 · cites it directly2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K010954Concentric Balloon Guide Catheter, Model 90031Concentric Medical, Inc.20011
−5K021899Concentric Balloon Guide Catheter, Model 90072Concentric Medical, Inc.20021
−4K053491Penumbra Balloon Guide Catheter, Model 7.5FPenumbra, Inc.2006—
−3K070970Neuron Support Catheter System, Model 5F/6FPenumbra, Inc.20071
−2K082290Neuron Delivery Catheter 070Penumbra, Inc.20081
−1K111380Neuron Max SystemPenumbra, Inc.2011—
0 (this device)K152876Long Sheath or LS, 70 CM, Long Sheath or LS, 80 CM, Long Sheath or LS, 90 CMTni Manufacturing, Inc.2016—
+1K191551RIST Cath Radial Access Long SheathRist Neurovascular, Inc.2019—
+2K231393Radical the Dude 7F Guide CatheterMaduro Medical, Inc.2023—
+2K211990Rist 071 Radial Access Guide CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular2021—
+1K191717Route 92 Medical Sheath SystemRoute 92 Medical, Inc.2020—
+1K172468091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cmInneuroco, Inc.20171

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110
200810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201710
201920
202010
202110
202310
202431
202520
202620
FIG. 1 — Lineage of K152876, 2001–2026Source: 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), 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.

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? (1)

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
*K111380Neuron Max System
Summary page 5
…urer 510(k) Number NEURON MAX SYSTEM Penumbra, Inc. K111380 Alameda, California Device Description The Long Sheath or LS is a variable sti…
Penumbra, Inc.2011—

Also cleared against K111380: 9 other devices →

What descends from it? (13)

See all 13

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

NumberDeviceApplicantDecidedDescendants
K191551RIST Cath Radial Access Long SheathRist Neurovascular, Inc.20196
K191717Route 92 Medical Sheath SystemRoute 92 Medical, Inc.20202
K172468091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cmInneuroco, Inc.20172

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

Recalls of this device

DateClassRecallRoot causeReason
May 2, 2018Class IIZ-3281-2018Nonconforming Material/ComponentThe AXS Infinity LS Long Sheath Dilator outer diameter (OD) specification was exceeded.

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.

  • K242376Next Generation Access PlatformBalt USA, LLC · 2024 · 2 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
  • 6 of the 8 ancestors have a recall of any class.
  • Of its descendants, K191551 (Rist Neurovascular, Inc., 2019) has gone furthest, with 6 descendants of its own.
  • 9 other devices also cite its predicate K111380.

How does its category compare?

All DQY devices

DQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.

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?

The Long Sheath is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro

vasulature.

Indications for use as stated in the FDA summary.

Also cleared against K111380

9 other devices cite the same predicate.

  • K253359Zenith Distal Access Long SheathSuzhou Zenith Vascular SciTech Limited · 2026
  • K2226036F Wallaby Long SheathWallaby Medical, Inc. · 2023
  • K222358Indigo Aspiration System - Lightning FlashPenumbra, Inc. · 2022
  • K201271Benchmark BMX96 Access SystemPenumbra, Inc. · 2020
  • K200910BOSS Balloon Guide CatheterMarblehead Medical · 2020
  • K192804CEREBASE DA Guide Sheath, 95cm, CEREBASE DA Guide Sheath, 90cm, CEREBASE DA Guide Sheath, 80cm, CEREBASE DA…Medos International SARL · 20201 Class I recall

More from Tni Manufacturing, Inc.

2 FDA decisions under this applicant name. See the company

  • K152202Intermediate Catheter, 105 cm, Intermediate Catheter, 115cm, Intermediate Catheter , 125cmTni Manufacturing, Inc. · 2015

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/K152876 · printed Nov 5, 2026

Cite this page

510(k) Report. “K152876: Long Sheath or LS, 70 CM, Long Sheath or LS, 80 CM, Long Sheath or LS, 90 CM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K152876

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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