510(k) Report

510(k) · Cleared

Cleared

AXS Catalyst Distal Access Catheter 058 x 115cm; AXS Catalyst Distal Access Catheter 058 x 132cm; AXS Catalyst Distal Access Catheter 060 x 132cm

K173841510(k) TraditionalCleared Mar 18, 201890-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

Stryker · NRY Catheter, Thrombus Retriever

Cleared on Mar 18, 2018 as substantially equivalent to K090752 (Penumbra, Inc., 2009) and 1 other predicate after a 90-day review. Its family tree reaches back 9 generations to 2001. 6 later devices descend from it.

Decided
Mar 18, 2018
Review
90 days
Class
Class II
Product code
NRY
Recalls
None
Predicates
2

Its longest line of descent runs back 9 generations to K003410 (2001). 13 ancestors in all, the oldest K003086 (2001). 6 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2009: 1 other ancestor2012: 1 other ancestor2014: 1 other ancestor2001: 1 other ancestor2019: 1 descendant cleared2024: 1 descendant cleared2025: 3 descendants cleared2026: 1 descendant clearedReference device: K151667 · AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access Catheter 058x132cm, AXS Catalyst Distal Access Catheter 060x132cm · Stryker · 2015 · recalledK003410 · 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. · 2016K160449 · Penumbra System, Penumbra Pump MAX · Penumbra, Inc. · 2016200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 1 other ancestor4 generations back: 1 other ancestor5 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 3 descendants3 generations forward: 1 descendant K160449 · Penumbra System, Penumbra Pump MAX · 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 backK160449 Penumbra System, Penumbra Pump MAXPenumbra, Inc. · 2016
  6. This deviceK173841 AXS Catalyst Distal Access Catheter 058 x 115cm; AXS Catalyst Distal…Stryker · 2018
  7. Descendant · cites it directly · 4 of its ownK232971 APRO 55 Catheter and Alembic Aspiration TubingAlembic, LLC · 2024
  8. Descendant · 2 generations on · 1 of its ownK251015 APRO 45 Catheter and Alembic Aspiration TubingAlembic, LLC · 2025
  9. Descendant · 3 generations on · 0 of its ownK262391 APRO 35 Swift Catheter and Alembic Aspiration TubingAlembic, LLC · 2026
  10. Descendant · 2 generations on · 0 of its ownK250958 APRO 55 Swift Catheter and Alembic Aspiration TubingAlembic, LLC · 2025
  11. Descendant · 2 generations on · 0 of its ownK243287 APRO 70 Swift Catheter and Alembic Aspiration TubingAlembic, LLC · 2025
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 backK160449 Penumbra System, Penumbra Pump MAXPenumbra, Inc. · 2016
  10. This deviceK173841 AXS Catalyst Distal Access Catheter 058 x 115cm; AXS Catalyst Distal…Stryker · 2018

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2019: 12024: 12025: 32026: 1
2019high 3 (2025) · low 0 (2020)2026

Most influential descendants

Showing 5 of 6 · See all
  • K232971APRO 55 Catheter and Alembic Aspiration TubingAlembic, LLC · 2024 · cites it directly4descendants
  • K251015APRO 45 Catheter and Alembic Aspiration TubingAlembic, LLC · 2025 · 2 generations on1descendant
  • K262391APRO 35 Swift Catheter and Alembic Aspiration TubingAlembic, LLC · 2026 · 3 generations on0descendants
  • K250958APRO 55 Swift Catheter and Alembic Aspiration TubingAlembic, LLC · 2025 · 2 generations on0descendants
  • K243287APRO 70 Swift Catheter and Alembic Aspiration TubingAlembic, LLC · 2025 · 2 generations on0descendants
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—
−1K160449Penumbra System, Penumbra Pump MAXPenumbra, Inc.2016—
0 (this device)K173841AXS Catalyst Distal Access Catheter 058 x 115cm; AXS Catalyst Distal Access…Stryker2018—
+1K232971APRO 55 Catheter and Alembic Aspiration TubingAlembic, LLC2024—
+2K251015APRO 45 Catheter and Alembic Aspiration TubingAlembic, LLC2025—
+3K262391APRO 35 Swift Catheter and Alembic Aspiration TubingAlembic, LLC2026—
+2K250958APRO 55 Swift Catheter and Alembic Aspiration TubingAlembic, LLC2025—
+2K243287APRO 70 Swift Catheter and Alembic Aspiration TubingAlembic, LLC2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110
200910
201210
201410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201910
202410
202530
202610
FIG. 1 — Lineage of K173841, 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.

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
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
*K090752Penumbra System (Pennumbra Reperfusion Catheter 054), Model PSC054; (Penumbra Separator…
Summary page 5
…mbra Reperfusion AXS Catalyst Distal Access Predicate Catheter Catheter Device(s): (K090752) (K151667) Aspiration Penumbra Max Pump N/A System Penumbra…
Penumbra, Inc.2009—
*K160449Penumbra System, Penumbra Pump MAX
Summary page 5
…N/A System Penumbra Hi-Flo Aspiration Components Tubing Penumbra MAX Canister (K160449) Device Description The AXS Catalyst Distal Access Catheter as part of the AXS Universal Aspiration System is designed to resto…
Penumbra, Inc.2016—
†K151667AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access Catheter…Stryker20153

Also cleared against K090752: 10 other devices →

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K232971APRO 55 Catheter and Alembic Aspiration TubingAlembic, LLC20244
K183464AXS Catalyst 7 Distal Access Catheter (068 x 115cm, 068 x 125cm, 068 x 132cm)Stryker20190

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.

What does this lineage say?

  • The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
  • 3 of the 13 ancestors have a recall of any class.
  • Of its descendants, K232971 (Alembic, LLC, 2024) has gone furthest, with 4 descendants of its own.
  • 10 other devices also cite its predicate K090752.

How does its category compare?

All NRY devices

NRY Catheter, Thrombus Retriever: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 AXS Catalyst Distal Access Catheter as part of the AXS Universal Aspiration System is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (in 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 are candidates for treatment.

Indications for use as stated in the FDA summary.

Also cleared against K090752

10 other devices cite the same predicate.

  • K252707Zenith Aspiration Catheter; Disposable Aspiration Tubing SetSuzhou Zenith Vascular SciTech Limited · 2026
  • K233329Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing SetRoute 92 Medical, Inc. · 2024
  • K211697Esperance Aspiration Catheter SystemWallaby Medical · 2021
  • K142458Penumbra System ACEPenumbra, Inc. · 2015
  • K133317Penumbra System / Penumbra System MaxPenumbra, Inc. · 2014
  • K122772Penumbra DDC CathetersPenumbra, Inc. · 2012

More from Stryker

92 FDA decisions under this applicant name. See the company

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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/K173841 · printed Nov 6, 2026

Cite this page

510(k) Report. “K173841: AXS Catalyst Distal Access Catheter 058 x 115cm; AXS Catalyst Distal Access Catheter 058 x 132cm; AXS Catalyst Distal Access Catheter 060 x 132cm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173841

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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