510(k) Report

510(k) · Cleared

Recalled · Class I · 2024

Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set

K223530510(k) TraditionalCleared Apr 11, 2023139-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

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

Cleared on Apr 11, 2023 as substantially equivalent to K161064 (Penumbra, Inc., 2016) after a 139-day review. Its family tree reaches back 9 generations to 2001. 1 of the 13 devices in its family, counting itself, has a Class I recall. It has been recalled once, including a Class I recall.

Decided
Apr 11, 2023
Review
139 days
Class
Class II
Product code
NRY
Recalls
1 (1 Class I)
Predicates
1

Its longest line of descent runs back 9 generations to K003410 (2001). 12 ancestors in all, the oldest K003086 (2001). No later device cites it as a predicate yet. 1 of the 13 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year cleared 2014: 1 other ancestor2009: 1 other ancestor2001: 1 other ancestorReference device: K222743 · Route 92 Medical Full Length 070 Access System · Route 92 Medical, Inc. · 2022 · Class I recallK003410 · Concentric Retriever, Model 90030 · Concentric Medical, Inc. · 2001 · recalledK030476 · Modified Concentric Retriever, Model 90037 · Concentric Medical, Inc. · 2003 · recalledK033736 · Merci Retriever, Models 90065, 90066 · Concentric Medical, Inc. · 2004K072718 · Penumbra System · Penumbra, Inc. · 2007 · recalledK100769 · Penumbra System Separator Flex (026,032,041,054), Models PSF026, PSF032, PSF041, PSF054 · Penumbra, Inc. · 2010K113163 · Penumbra System Max · Penumbra, Inc. · 2011K142458 · Penumbra System ACE · Penumbra, Inc. · 2015K152541 · Penumbra System ACE 64 and ACE 68 Reperfusion Catheters · Penumbra, Inc. · 2016K161064 · Penumbra System ACE 68 Reperfusion Catheter · Penumbra, Inc. · 2016200020052010201520202025
Other ancestors, by generation 4 generations back: 2 other ancestors5 generations back: 1 other ancestor K161064 · Penumbra System ACE 68 Reperfusion Catheter · Penumbra, Inc. · 2016K152541 · Penumbra System ACE 64 and ACE 68 Reperfusion Catheters · Penumbra, Inc. · 2016K142458 · Penumbra System ACE · Penumbra, Inc. · 2015K113163 · Penumbra System Max · Penumbra, Inc. · 2011K100769 · Penumbra System Separator Flex (026,032,041,054), Models PSF026, PSF032, PSF041, PSF054 · Penumbra, Inc. · 2010K072718 · Penumbra System · Penumbra, Inc. · 2007 · recalledK033736 · Merci Retriever, Models 90065, 90066 · Concentric Medical, Inc. · 2004K030476 · Modified Concentric Retriever, Model 90037 · Concentric Medical, Inc. · 2003 · recalledK003410 · Concentric Retriever, Model 90030 · Concentric Medical, Inc. · 2001 · recalled−50
  1. Root · 9 generations backK003410 Concentric Retriever, Model 90030Concentric Medical, Inc. · 2001 · Recalled
  2. 5 generations between
  3. 3 generations backK142458 Penumbra System ACEPenumbra, Inc. · 2015
  4. 2 generations backK152541 Penumbra System ACE 64 and ACE 68 Reperfusion CathetersPenumbra, Inc. · 2016
  5. 1 generation backK161064 Penumbra System ACE 68 Reperfusion CatheterPenumbra, Inc. · 2016
  6. This deviceK223530 Route 92 Medical Full Length 070 Reperfusion System and Aspiration…Route 92 Medical, Inc. · 2023
Show all 9 generations
  1. Root · 9 generations backK003410 Concentric Retriever, Model 90030Concentric Medical, Inc. · 2001 · Recalled
  2. 8 generations backK030476 Modified Concentric Retriever, Model 90037Concentric Medical, Inc. · 2003 · Recalled
  3. 7 generations backK033736 Merci Retriever, Models 90065, 90066Concentric Medical, Inc. · 2004
  4. 6 generations backK072718 Penumbra SystemPenumbra, Inc. · 2007 · Recalled
  5. 5 generations backK100769 Penumbra System Separator Flex (026,032,041,054), Models PSF026…Penumbra, Inc. · 2010
  6. 4 generations backK113163 Penumbra System MaxPenumbra, Inc. · 2011
  7. 3 generations backK142458 Penumbra System ACEPenumbra, Inc. · 2015
  8. 2 generations backK152541 Penumbra System ACE 64 and ACE 68 Reperfusion CathetersPenumbra, Inc. · 2016
  9. 1 generation backK161064 Penumbra System ACE 68 Reperfusion CatheterPenumbra, Inc. · 2016
  10. This deviceK223530 Route 92 Medical Full Length 070 Reperfusion System and Aspiration…Route 92 Medical, Inc. · 2023
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−9K003410Concentric Retriever, Model 90030Concentric Medical, Inc.20011
−8K030476Modified Concentric Retriever, Model 90037Concentric Medical, Inc.20032
−7K033736Merci Retriever, Models 90065, 90066Concentric Medical, Inc.2004—
−6K072718Penumbra SystemPenumbra, Inc.20071
−5K100769Penumbra System Separator Flex (026,032,041,054), Models PSF026, PSF032…Penumbra, Inc.2010—
−4K113163Penumbra System MaxPenumbra, Inc.2011—
−3K142458Penumbra System ACEPenumbra, Inc.2015—
−2K152541Penumbra System ACE 64 and ACE 68 Reperfusion CathetersPenumbra, Inc.2016—
−1K161064Penumbra System ACE 68 Reperfusion CatheterPenumbra, Inc.2016—
0 (this device)K223530Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing SetRoute 92 Medical, Inc.2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110
200910
201410
FIG. 1 — Lineage of K223530, 2001–2023Source: 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 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
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
*K161064Penumbra System ACE 68 Reperfusion Catheter
Summary page 4
…Class II Predicate Device: Penumbra System ACE 68 Reperfusion Catheter K161064 Reference Device: Route 92 Medical Full Length 070 Access System,…
Penumbra, Inc.2016—
†K222743Route 92 Medical Full Length 070 Access SystemRoute 92 Medical, Inc.2022Class I

Also cleared against K161064: 4 other devices →

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
Mar 8, 2024Class IZ-1611-2024Process controlTheir is the potential for distal tip separation at the proximal marker band of the delivery catheters

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
  • 3 of the 12 ancestors have a recall of any class.
  • 4 other devices also cite its predicate K161064.

How does its category compare?

All NRY devices

NRY Catheter, Thrombus Retriever: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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—

What is it indicated for?

The Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral – M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who failed IV t-PA therapy are candidates for treatment.

Indications for use as stated in the FDA summary.

Also cleared against K161064

4 other devices cite the same predicate.

  • K193380CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing SetCodman & Shurtleff, Inc. · 2020
  • K182101Riptide Aspiration System (React 71 Catheter)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2018
  • K180705Riptide Aspiration System React 68 CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2018
  • K172167Zenith Flex SystemInneuroco, Inc. · 20181 recall

More from Route 92 Medical, Inc.

15 FDA decisions under this applicant name. See the company

  • K263266Route 92 Medical Full Length 046 Reperfusion System and Aspiration Tubing SetRoute 92 Medical, Inc. · 2026
  • 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

Recent decisions in NRY

The NRY category page

  • K262021Toro 71 Aspiration Catheter; Toro Aspiration TubingToro Neurovascular, Inc. · 2026
  • K263266Route 92 Medical Full Length 046 Reperfusion System and Aspiration Tubing SetRoute 92 Medical, 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

https://510kreport.com/device/K223530 · printed Nov 6, 2026

Cite this page

510(k) Report. “K223530: Route 92 Medical Full Length 070 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/K223530

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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