510(k) Report

510(k) · Cleared

Recalled · Class I · 2021

0.071” ID MantaRay Reperfusion Catheter, 0.055” ID MantaRay Reperfusion Catheter, 0.045” ID MantaRay Reperfusion Catheter, 0.035” ID MantaRay Reperfusion Catheter

K183043510(k) TraditionalCleared Apr 17, 2019166-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

Imperative Care, Inc. · NRY Catheter, Thrombus Retriever

Cleared on Apr 17, 2019 after a 166-day review. The FDA summary names no predicate by number. 3 of the 8 devices in its family, counting itself, have a Class I recall. 7 later devices descend from it. It has been recalled once, including a Class I recall.

Decided
Apr 17, 2019
Review
166 days
Class
Class II
Product code
NRY
Recalls
1 (1 Class I)
Predicates
0

7 later devices descend from it, 1 citing it directly. 3 of the 8 devices in this family, counting this one, have a Class I recall.

Descendants, by year cleared 2020: 1 descendant cleared, 1 with a Class I recall12021: 2 descendants cleared, 1 with a Class I recall12025: 3 descendants cleared2024: 1 descendant cleared201620182020202220242026
  1. This deviceK183043 0.071” ID MantaRay Reperfusion Catheter, 0.055” ID MantaRay…Imperative Care, Inc. · 2019
  2. Descendant · cites it directly · 6 of its ownK202182 ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration TubingImperative Care, Inc. · 2020 · Recalled (Class I)
  3. Descendant · 2 generations on · 5 of its ownK210996 ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration TubingImperative Care, Inc. · 2021 · Recalled (Class I)
  4. Descendant · 3 generations on · 3 of its ownK211476 ZOOM 71 Reperfusion Catheter; ZOOM Aspiration TubingImperative Care, Inc. · 2021
  5. Descendant · 3 generations on · 0 of its ownK243948 Raptor Aspiration Catheter; Balt Aspiration Tubing SetBalt USA, LLC · 2025
  6. Descendant · 4 generations on · 0 of its ownK243047 Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration TubingImperative Care, Inc. · 2025

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2020: 12021: 22024: 12025: 3
2020high 3 (2025) · low 0 (2022)2026

Class I recalls in this family

  • K202182 ZOOM (71, 55, 45, 35) Reperfusion Catheters…cites it directly · 2020
  • K210996 ZOOM (71, 55, 45, 35) Reperfusion Catheters…2 generations on · 2021

Most influential descendants

Showing 5 of 7 · See all
  • K202182ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration TubingImperative Care, Inc. · 2020 · cites it directly6descendants
  • K210996ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration TubingImperative Care, Inc. · 2021 · 2 generations on5descendants
  • K211476ZOOM 71 Reperfusion Catheter; ZOOM Aspiration TubingImperative Care, Inc. · 2021 · 3 generations on3descendants
  • K243948Raptor Aspiration Catheter; Balt Aspiration Tubing SetBalt USA, LLC · 2025 · 3 generations on0descendants
  • K243047Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration TubingImperative Care, Inc. · 2025 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K1830430.071” ID MantaRay Reperfusion Catheter, 0.055” ID MantaRay Reperfusion…Imperative Care, Inc.2019—
+1K202182ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration TubingImperative Care, Inc.2020Class I
+2K210996ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration TubingImperative Care, Inc.2021Class I
+3K211476ZOOM 71 Reperfusion Catheter; ZOOM Aspiration TubingImperative Care, Inc.2021—
+3K243948Raptor Aspiration Catheter; Balt Aspiration Tubing SetBalt USA, LLC2025—
+4K243047Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration TubingImperative Care, Inc.2025—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202011
202121
202410
202530
FIG. 1 — Lineage of K183043, 2019–2025Source: 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.

3 devices in this family have 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?

The FDA summary names no predicate by number.

What descends from it? (7)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K202182ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing Class IImperative Care, Inc.20206

Has anything in its family been recalled? (3 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Aug 13, 2021Class IZ-2577-2021Under Investigation by firmThere is a potential for distal end of catheters to fracture and become detached.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K202182ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration TubingImperative Care, Inc. · 2020 · Cites it directly · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
  • K210996ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration TubingImperative Care, Inc. · 2021 · 2 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K202182 (Imperative Care, Inc., 2020) has gone furthest, with 6 descendants of its own.

How does its category compare?

All NRY devices

NRY Catheter, Thrombus Retriever: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 Imperative Care, Inc.

18 FDA decisions under this applicant name. See the company

  • K261176Zoom 4S CatheterImperative Care, Inc. · 2026
  • K252046Zoom System (Zoom 4S Catheter)Imperative Care, Inc. · 2025
  • K252057Symphony™ Thrombectomy System and Symphony™ 16F 82cm Thrombectomy SystemImperative Care, Inc. · 2025
  • K244061X-Wire GuidewireImperative Care, Inc. · 2025
  • K243047Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration TubingImperative Care, Inc. · 2025

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/K183043 · printed Nov 6, 2026

Cite this page

510(k) Report. “K183043: 0.071” ID MantaRay Reperfusion Catheter, 0.055” ID MantaRay Reperfusion Catheter, 0.045” ID MantaRay Reperfusion Catheter, 0.035” ID MantaRay Reperfusion Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183043

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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