510(k) Report

510(k) · Cleared

Cleared

Socrates Aspiration System (Socrates 70 Aspiration Catheter)

K260002510(k) TraditionalCleared Jul 16, 2026195-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

Scientia Vascular, Inc. · NRY Catheter, Thrombus Retriever

Cleared on Jul 16, 2026 as substantially equivalent to K161640 (Penumbra, Inc., 2016) after a 195-day review. Its family tree reaches back 10 generations to 2001.

Decided
Jul 16, 2026
Review
195 days
Class
Class II
Product code
NRY
Recalls
None
Predicates
1

Its longest line of descent runs back 10 generations to K003410 (2001). 14 ancestors in all, the oldest K003086 (2001). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2012: 1 other ancestor2014: 1 other ancestor2009: 1 other ancestor2001: 1 other ancestorReference device: K191768 · AXS Vecta Aspiration System · Stryker Neurovascular · 2019K003410 · 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. · 2016×2: 2 generations cleared close together, K160449 (2016), K161640 (2016) 200020052010201520202025
Other ancestors, by generation 3 generations back: 1 other ancestor5 generations back: 2 other ancestors6 generations back: 1 other ancestor K161640 · Penumbra System ACE 68 Reperfusion Catheter · Penumbra, Inc. · 2016K160449 · 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−10−50
  1. Root · 10 generations backK003410 Concentric Retriever, Model 90030Concentric Medical, Inc. · 2001 · Recalled
  2. 6 generations between
  3. 3 generations backK152541 Penumbra System ACE 64 and ACE 68 Reperfusion CathetersPenumbra, Inc. · 2016
  4. 2 generations backK160449 Penumbra System, Penumbra Pump MAXPenumbra, Inc. · 2016
  5. 1 generation backK161640 Penumbra System ACE 68 Reperfusion CatheterPenumbra, Inc. · 2016
  6. This deviceK260002 Socrates Aspiration System (Socrates 70 Aspiration Catheter)Scientia Vascular, Inc. · 2026
Show all 10 generations
  1. Root · 10 generations backK003410 Concentric Retriever, Model 90030Concentric Medical, Inc. · 2001 · Recalled
  2. 9 generations backK030476 Modified Concentric Retriever, Model 90037Concentric Medical, Inc. · 2003 · Recalled
  3. 8 generations backK033736 Merci Retriever, Models 90065, 90066Concentric Medical, Inc. · 2004
  4. 7 generations backK072718 Penumbra SystemPenumbra, Inc. · 2007 · Recalled
  5. 6 generations backK100769 Penumbra System Separator Flex (026,032,041,054), Models PSF026…Penumbra, Inc. · 2010
  6. 5 generations backK113163 Penumbra System MaxPenumbra, Inc. · 2011
  7. 4 generations backK142458 Penumbra System ACEPenumbra, Inc. · 2015
  8. 3 generations backK152541 Penumbra System ACE 64 and ACE 68 Reperfusion CathetersPenumbra, Inc. · 2016
  9. 2 generations backK160449 Penumbra System, Penumbra Pump MAXPenumbra, Inc. · 2016
  10. 1 generation backK161640 Penumbra System ACE 68 Reperfusion CatheterPenumbra, Inc. · 2016
  11. This deviceK260002 Socrates Aspiration System (Socrates 70 Aspiration Catheter)Scientia Vascular, Inc. · 2026
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−10K003410Concentric Retriever, Model 90030Concentric Medical, Inc.20011
−9K030476Modified Concentric Retriever, Model 90037Concentric Medical, Inc.20032
−8K033736Merci Retriever, Models 90065, 90066Concentric Medical, Inc.2004—
−7K072718Penumbra SystemPenumbra, Inc.20071
−6K100769Penumbra System Separator Flex (026,032,041,054), Models PSF026, PSF032…Penumbra, Inc.2010—
−5K113163Penumbra System MaxPenumbra, Inc.2011—
−4K142458Penumbra System ACEPenumbra, Inc.2015—
−3K152541Penumbra System ACE 64 and ACE 68 Reperfusion CathetersPenumbra, Inc.2016—
−2K160449Penumbra System, Penumbra Pump MAXPenumbra, Inc.2016—
−1K161640Penumbra System ACE 68 Reperfusion CatheterPenumbra, Inc.2016—
0 (this device)K260002Socrates Aspiration System (Socrates 70 Aspiration Catheter)Scientia Vascular, Inc.2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110
200910
201210
201410
FIG. 1 — Lineage of K260002, 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? (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
*K161640Penumbra System ACE 68 Reperfusion Catheter
Summary page 5
…el: Neurology Device Class: Class II PREDICATE DEVICE Trade Name: Penumbra System ACE 68 Reperfusion Catheter Predicate 510(k) Number: K161640 REFERENCE DEVICE Trade Name: AXS Vecta Aspiration System Reference Device 510(k) Number: K191768…
Penumbra, Inc.2016—
†K191768AXS Vecta Aspiration SystemStryker Neurovascular2019—

Also cleared against K161640: 5 other devices →

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.

What does this lineage say?

  • The line of descent spans 25 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
  • 3 of the 14 ancestors have a recall of any class.
  • 5 other devices also cite its predicate K161640.

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—

What is it indicated for?

Socrates Aspiration Catheters As part of the Socrates Aspiration System, the Socrates Aspiration Catheters with a compatible suction pump are 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…

Read the full statement (106 words)

Socrates Aspiration Catheters

As part of the Socrates Aspiration System, the Socrates Aspiration Catheters with a compatible suction pump are 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 thrombolytic drug therapy or who failed thrombolytic drug therapy are candidates for treatment.

Socrates Aspiration Tubing

As part of the Socrates Aspiration System, the Socrates Aspiration Tubing is indicated to connect the Socrates Aspiration Catheters to a compatible suction pump.

Indications for use as stated in the FDA summary.

Also cleared against K161640

5 other devices cite the same predicate.

  • K252707Zenith Aspiration Catheter; Disposable Aspiration Tubing SetSuzhou Zenith Vascular SciTech Limited · 2026
  • K211411Penumbra System (RED 68 Reperfusion Catheter)Penumbra, Inc. · 20211 recall
  • K203440Penumbra System (Reperfusion Catheter RED 62)Penumbra, Inc. · 20211 recall
  • K183464AXS Catalyst 7 Distal Access Catheter (068 x 115cm, 068 x 125cm, 068 x 132cm)Stryker · 2019
  • K173761Penumbra System Reperfusion Catheter JET 7Penumbra, Inc. · 2018

More from Scientia Vascular, Inc.

9 FDA decisions under this applicant name. See the company

  • K260223Aristotle Mini GuidewireScientia Vascular, Inc. · 2026
  • K253579Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 GuidewireScientia Vascular, Inc. · 2026
  • K243938Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire; Aristotle…Scientia Vascular, Inc. · 2025
  • K242301Socrates 38 CatheterScientia Vascular, Inc. · 2024
  • K223913Socrates Aspiration SystemScientia Vascular, Inc. · 20231 recall

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/K260002 · printed Nov 6, 2026

Cite this page

510(k) Report. “K260002: Socrates Aspiration System (Socrates 70 Aspiration Catheter).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260002

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Record history
  • FDA decision record loaded Oct 30, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026