510(k) Report

510(k) · Cleared

Cleared

Route 92 Medical Full Length 046 Reperfusion System and Aspiration Tubing Set

K263266510(k) SpecialCleared Oct 16, 202628-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

Route 92 Medical, Inc. · NRY Catheter, Thrombus Retriever

Cleared on Oct 16, 2026 after a 28-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Oct 16, 2026
Review
28 days
Class
Class II
Product code
NRY
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K263266Source: FDA 510(k) database · 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 NRY? 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 NRY device

  1. #1 K232971 APRO 55 Catheter and Alembic Aspiration Tubingscore 18.6 · 10 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?

No later submission names this one as a predicate yet.

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.

How does its category compare?

All NRY devices

NRY Catheter, Thrombus Retriever: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.

FDA decisions per year · NRY

15in 2025

2007: 52008: 22009: 22010: 12011: 22012: 42014: 42015: 62016: 52017: 32018: 112019: 72020: 62021: 92022: 32023: 82024: 82025: 152026 (partial year): 14
2007high 15 (2025) · low 0 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NRY

129in 2025

2007: 94 days median2012: 90 days median2014: 140 days median2015: 128 days median2016: 75 days median2017: 185 days median2018: 156 days median2019: 89 days median2020: 125 days median2021: 80 days median2022: 129 days median2023: 112 days median2024: 165 days median2025: 129 days median2026 (partial year): 147 days median
2007high 185 (2017) · low 75 (2016)2026

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

Recalls per year · NRY

4in 2020

2010: 12013: 12017: 42020: 4, 4 Class I2026 (partial year): 2
2007high 4 (2017) · low 0 (2007)2026

Class I (4 since 2007) Class II/III not classified

Adverse event reports per year · NRY

565in 2025

2007: 132008: 182009: 572010: 2892011: 2632012: 3662013: 4052014: 4282015: 5982016: 4972017: 4322018: 4152019: 6502020: 7032021: 6882022: 5492023: 7112024: 6412025: 565
2007high 711 (2023) · low 13 (2007)2025

MAUDE reports naming product code NRY, 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
2007594013
20082—018
20092—057
20101—1289
20112—0263
20124900366
20130—1405
201441400428
201561280598
20165750497
201731854432
2018111560415
20197890650
202061254 (4)703
20219800688
202231290549
202381120711
202481650641
2025151290565
2026141472—

More from Route 92 Medical, Inc.

15 FDA decisions under this applicant name. See the company

  • K260220Route 92 Medical Full Length 046 Access SystemRoute 92 Medical, Inc. · 2026
  • K243601Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing SetRoute 92 Medical, Inc. · 2025
  • K2405298F Modified Sheath SystemRoute 92 Medical, Inc. · 2024
  • K233329Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing SetRoute 92 Medical, Inc. · 2024
  • K231583Route 92 Medical Full Length 054 Access SystemRoute 92 Medical, Inc. · 2023

Recent decisions in NRY

The NRY category page

  • K262021Toro 71 Aspiration Catheter; Toro Aspiration TubingToro Neurovascular, Inc. · 2026
  • K261089Radical 064 Reperfusion Catheter; Radical 076 Reperfusion Catheter; Radical Aspiration Tubing KitMaduro Medical, Inc. · 2026
  • K260617Tigertriever 13 Ultra Revascularization DeviceRapid Medical Ltd. · 2026
  • K262398CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing setCERENOVUS, Inc. · 2026
  • K262399Millipede SystemPerfuze, Ltd. · 2026

https://510kreport.com/device/K263266 · printed Nov 6, 2026

Cite this page

510(k) Report. “K263266: Route 92 Medical Full Length 046 Reperfusion System and Aspiration Tubing Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K263266

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Record history
  • FDA decision record loaded Oct 30, 2026
  • Page last updated Nov 3, 2026