510(k) Report

510(k) · Cleared

Recalled · Class I · 2025

Next Generation Access Platform

K242376510(k) TraditionalCleared Dec 30, 2024143-day reviewClass II21 CFR 870.1250Recalls 1 (1 Class I)

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

Balt USA, LLC · QJP Catheter, Percutaneous, Neurovasculature

Cleared on Dec 30, 2024 as substantially equivalent to K182918 (Balt USA, LLC, 2019) and 1 other predicate after a 143-day review. Its family tree reaches back 8 generations to 2001. 1 of the 12 devices in its family, counting itself, has a Class I recall. It has been recalled once, including a Class I recall.

Decided
Dec 30, 2024
Review
143 days
Class
Class II
Product code
QJP
Recalls
1 (1 Class I)
Predicates
2

Its longest line of descent runs back 8 generations to K010954 (2001). 11 ancestors in all, the oldest K010853 (2001). No later device cites it as a predicate yet. 1 of the 12 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year cleared 2019: 1 other ancestor2008: 1 other ancestor2001: 1 other ancestorK010954 · 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. · 2011K152876 · Long Sheath or LS, 70 CM, Long Sheath or LS, 80 CM, Long Sheath or LS, 90 CM · Tni Manufacturing, Inc. · 2016 · recalledK191717 · Route 92 Medical Sheath System · Route 92 Medical, Inc. · 2020200020052010201520202025
Other ancestors, by generation 1 generation back: 1 other ancestor3 generations back: 1 other ancestor4 generations back: 1 other ancestor K191717 · Route 92 Medical Sheath System · Route 92 Medical, Inc. · 2020K152876 · Long Sheath or LS, 70 CM, Long Sheath or LS, 80 CM, Long Sheath or LS, 90 CM · Tni Manufacturing, Inc. · 2016 · recalledK111380 · 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 · 8 generations backK010954 Concentric Balloon Guide Catheter, Model 90031Concentric Medical, Inc. · 2001 · Recalled
  2. 7 generations backK021899 Concentric Balloon Guide Catheter, Model 90072Concentric Medical, Inc. · 2002 · Recalled
  3. 6 generations backK053491 Penumbra Balloon Guide Catheter, Model 7.5FPenumbra, Inc. · 2006
  4. 5 generations backK070970 Neuron Support Catheter System, Model 5F/6FPenumbra, Inc. · 2007 · Recalled
  5. 4 generations backK082290 Neuron Delivery Catheter 070Penumbra, Inc. · 2008 · Recalled
  6. 3 generations backK111380 Neuron Max SystemPenumbra, Inc. · 2011
  7. 2 generations backK152876 Long Sheath or LS, 70 CM, Long Sheath or LS, 80 CM, Long Sheath or…Tni Manufacturing, Inc. · 2016 · Recalled
  8. 1 generation backK191717 Route 92 Medical Sheath SystemRoute 92 Medical, Inc. · 2020
  9. This deviceK242376 Next Generation Access PlatformBalt USA, LLC · 2024
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−8K010954Concentric Balloon Guide Catheter, Model 90031Concentric Medical, Inc.20011
−7K021899Concentric Balloon Guide Catheter, Model 90072Concentric Medical, Inc.20021
−6K053491Penumbra Balloon Guide Catheter, Model 7.5FPenumbra, Inc.2006—
−5K070970Neuron Support Catheter System, Model 5F/6FPenumbra, Inc.20071
−4K082290Neuron Delivery Catheter 070Penumbra, Inc.20081
−3K111380Neuron Max SystemPenumbra, Inc.2011—
−2K152876Long Sheath or LS, 70 CM, Long Sheath or LS, 80 CM, Long Sheath or LS, 90 CMTni Manufacturing, Inc.20161
−1K191717Route 92 Medical Sheath SystemRoute 92 Medical, Inc.2020—
0 (this device)K242376Next Generation Access PlatformBalt USA, LLC2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110
200810
201910
FIG. 1 — Lineage of K242376, 2001–2024Source: 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 QJP device

  1. #1 K212838 Benchmark Intracranial Access Systemscore 16.9 · 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? (2)

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
*K182918Ballast 088 Long Sheath
Summary page 5
…uct Codes: QJP, DQY Regulation Number: 21 CFR 870.1250 Device Classification: Class II Predicate Devices: Ballast 088 Long Sheath (K182918) Base Camp Sheath System (K191717) Device Description: The Next Generation Access Platform consis…
Balt USA, LLC2019—
*K191717Route 92 Medical Sheath System
Summary page 5
…CFR 870.1250 Device Classification: Class II Predicate Devices: Ballast 088 Long Sheath (K182918) Base Camp Sheath System (K191717) Device Description: The Next Generation Access Platform consists of the Next Generation Access Sheath, Dilator, Introducer She…
Route 92 Medical, Inc.2020—

What descends from it?

No later submission names this one as a predicate yet.

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

Recalls of this device

DateClassRecallRoot causeReason
Sep 25, 2025Class IZ-0188-2026Process controlDue to an identified manufacturing defect involving coating material lifting within the catheter's distal inner diameter/lumen.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 23 years and passes through 5 companies; a new generation was cleared every 3.8 years on median.
  • 7 of the 11 ancestors have a recall of any class.

How does its category compare?

All QJP devices

QJP Catheter, Percutaneous, Neurovasculature: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.

FDA decisions per year · QJP

22so far in 2026, the most since 2007

2020: 92021: 122022: 142023: 142024: 182025: 142026 (partial year): 22
2007high 22 (2026) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QJP

116in 2025

2020: 72 days median2021: 139 days median2022: 206 days median2023: 184 days median2024: 188 days median2025: 116 days median2026 (partial year): 141 days median
2007high 206 (2022) · low 72 (2020)2026

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

Recalls per year · QJP

1in 2024

2024: 1
2007high 1 (2024) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · QJP

688in 2025

2020: 162021: 292022: 302023: 752024: 1302025: 688
2007high 688 (2025) · low 0 (2007)2025

MAUDE reports naming product code QJP, 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
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
2020972016
202112139029
202214206030
202314184075
2024181881130
2025141160688
2026221410—

What is it indicated for?

The Next Generation Access Platform is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

Indications for use as stated in the FDA summary.

More from Balt USA, LLC

22 FDA decisions under this applicant name. See the company

  • P250009/S001SQUID Liquid Embolic Agent (LEA)Balt USA, LLC · 2026
  • P250009/S002SQUID Liquid Embolic Agent (LEA)Balt USA, LLC · 2026
  • K260199SLIM MicrocatheterBalt USA, LLC · 2026
  • K254223Next Generation 088 CatheterBalt USA, LLC · 2026
  • P250009SQUID Liquid Embolic Agent (LEA)Balt USA, LLC · 2026

Recent decisions in QJP

The QJP category page

  • K261649Excelsior Reach MicrocatheterStryker Neurovascular · 2026
  • K261938APRO 88 CatheterAlembic, LLC · 2026
  • K253422OAB Delivery CatheterCognition Medical Corp. · 2026
  • K260220Route 92 Medical Full Length 046 Access SystemRoute 92 Medical, Inc. · 2026
  • K26227770 NeuGlide CatheterPiraeus Medical, Inc. · 2026

https://510kreport.com/device/K242376 · printed Nov 5, 2026

Cite this page

510(k) Report. “K242376: Next Generation Access Platform.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K242376

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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