510(k) · Cleared
Recalled · Class I · 2021ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Imperative Care, Inc. · NRY Catheter, Thrombus Retriever
Cleared on Sep 2, 2020 as substantially equivalent to K183043 (Imperative Care, Inc., 2019) after a 29-day review. Its family tree reaches back 1 generation to 2019. 3 of the 8 devices in its family, counting itself, have a Class I recall. 6 later devices descend from it. It has been recalled once, including a Class I recall.
- Decided
- Sep 2, 2020
- Review
- 29 days
- Class
- Class II
- Product code
- NRY
- Recalls
- 1 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 1 generation to K183043 (2019). 6 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.
- Root · 1 generation backK183043 0.071” ID MantaRay Reperfusion Catheter, 0.055” ID MantaRay…Imperative Care, Inc. · 2019 · Recalled (Class I)
- This deviceK202182 ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration TubingImperative Care, Inc. · 2020
- Descendant · cites it directly · 5 of its ownK210996 ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration TubingImperative Care, Inc. · 2021 · Recalled (Class I)
- Descendant · 2 generations on · 3 of its ownK211476 ZOOM 71 Reperfusion Catheter; ZOOM Aspiration TubingImperative Care, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK243948 Raptor Aspiration Catheter; Balt Aspiration Tubing SetBalt USA, LLC · 2025
- Descendant · 3 generations on · 0 of its ownK243047 Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration TubingImperative Care, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK242672 Zoom SystemImperative Care, Inc. · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 6 · See all- K210996ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration TubingImperative Care, Inc. · 2021 · cites it directly5descendants
- K211476ZOOM 71 Reperfusion Catheter; ZOOM Aspiration TubingImperative Care, Inc. · 2021 · 2 generations on3descendants
- K243948Raptor Aspiration Catheter; Balt Aspiration Tubing SetBalt USA, LLC · 2025 · 2 generations on0descendants
- K243047Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration TubingImperative Care, Inc. · 2025 · 3 generations on0descendants
- K242672Zoom SystemImperative Care, Inc. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K183043 | 0.071” ID MantaRay Reperfusion Catheter, 0.055” ID MantaRay Reperfusion… | Imperative Care, Inc. | 2019 | Class I |
| 0 (this device) | K202182 | ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing | Imperative Care, Inc. | 2020 | — |
| +1 | K210996 | ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing | Imperative Care, Inc. | 2021 | Class I |
| +2 | K211476 | ZOOM 71 Reperfusion Catheter; ZOOM Aspiration Tubing | Imperative Care, Inc. | 2021 | — |
| +2 | K243948 | Raptor Aspiration Catheter; Balt Aspiration Tubing Set | Balt USA, LLC | 2025 | — |
| +3 | K243047 | Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration Tubing | Imperative Care, Inc. | 2025 | — |
| +2 | K242672 | Zoom System | Imperative Care, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 2 | 1 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
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 K232971 APRO 55 Catheter and Alembic Aspiration Tubingscore 18.6 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K183043 | 0.071” ID MantaRay Reperfusion Catheter, 0.055” ID MantaRay Reperfusion Catheter, 0.045”…Summary page 4…NRY per 21 C.F.R. 870.1250 Manufacturer: Imperative Care Inc. 510(k) #: K183043 pg. 1 of 12 Imperative Care Inc. Special 510(k) Notification –… | 2019 |
| † | K190105 | ZOOM Aspiration Pump | 2019 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K210996 | ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing Class I | 2021 | 5 |
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 13, 2021 | Class I | Z-2577-2021 | Under Investigation by firm | There 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.
- K1830430.071” ID MantaRay Reperfusion Catheter, 0.055” ID MantaRay Reperfusion Catheter, 0.045” ID MantaRay…Imperative Care, Inc. · 2019 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K210996ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration TubingImperative Care, Inc. · 2021 · Cites it directly · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Its one ancestor has a recall, Class I.
- Of its descendants, K210996 (Imperative Care, Inc., 2021) has gone furthest, with 5 descendants of its own.
How does its category compare?
All NRY devicesNRY Catheter, Thrombus Retriever: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · NRY
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NRY
129in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NRY
4in 2020
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · NRY
565in 2025
MAUDE reports naming product code NRY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 5 | 94 | 0 | 13 |
| 2008 | 2 | — | 0 | 18 |
| 2009 | 2 | — | 0 | 57 |
| 2010 | 1 | — | 1 | 289 |
| 2011 | 2 | — | 0 | 263 |
| 2012 | 4 | 90 | 0 | 366 |
| 2013 | 0 | — | 1 | 405 |
| 2014 | 4 | 140 | 0 | 428 |
| 2015 | 6 | 128 | 0 | 598 |
| 2016 | 5 | 75 | 0 | 497 |
| 2017 | 3 | 185 | 4 | 432 |
| 2018 | 11 | 156 | 0 | 415 |
| 2019 | 7 | 89 | 0 | 650 |
| 2020 | 6 | 125 | 4 (4) | 703 |
| 2021 | 9 | 80 | 0 | 688 |
| 2022 | 3 | 129 | 0 | 549 |
| 2023 | 8 | 112 | 0 | 711 |
| 2024 | 8 | 165 | 0 | 641 |
| 2025 | 15 | 129 | 0 | 565 |
| 2026 | 14 | 147 | 2 | — |
What is it indicated for?
The ZOOM Reperfusion Catheters, with the ZOOM Aspiration Tubing and ZOOM Aspiration Pump (or equivalent vacuum 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 tissue plasminogen…
Read the full statement (110 words)
The ZOOM Reperfusion Catheters, with the ZOOM Aspiration Tubing and ZOOM Aspiration Pump (or equivalent vacuum 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 tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
The ZOOM Aspiration Tubing is intended to connect the ZOOM Reperfusion Catheter to the ZOOM Canister of the ZOOM Aspiration Pump and to allow the user to control the fluid flow.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202182 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202182: ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202182
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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