510(k) · Cleared
ClearedZOOM 71 Reperfusion Catheter; 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 Jun 8, 2021 as substantially equivalent to K210996 (Imperative Care, Inc., 2021) after a 27-day review. Its family tree reaches back 3 generations to 2019. 3 of the 7 devices in its family, counting itself, have a Class I recall. 3 later devices descend from it.
- Decided
- Jun 8, 2021
- Review
- 27 days
- Class
- Class II
- Product code
- NRY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K183043 (2019). 3 later devices descend from it, 3 citing it directly. 3 of the 7 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK183043 0.071” ID MantaRay Reperfusion Catheter, 0.055” ID MantaRay…Imperative Care, Inc. · 2019 · Recalled (Class I)
- 2 generations backK202182 ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration TubingImperative Care, Inc. · 2020 · Recalled (Class I)
- 1 generation backK210996 ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration TubingImperative Care, Inc. · 2021 · Recalled (Class I)
- This deviceK211476 ZOOM 71 Reperfusion Catheter; ZOOM Aspiration TubingImperative Care, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK243047 Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration TubingImperative Care, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK242672 Zoom SystemImperative Care, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK234083 Next Generation Aspiration Catheter; Balt Aspiration Tubing SetBalt USA, LLC · 2024
Class I recalls in this family
Most influential descendants
Showing 3 of 3 · See all- K243047Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration TubingImperative Care, Inc. · 2025 · cites it directly0descendants
- K242672Zoom SystemImperative Care, Inc. · 2025 · cites it directly0descendants
- K234083Next Generation Aspiration Catheter; Balt Aspiration Tubing SetBalt USA, LLC · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K183043 | 0.071” ID MantaRay Reperfusion Catheter, 0.055” ID MantaRay Reperfusion… | Imperative Care, Inc. | 2019 | Class I |
| −2 | K202182 | ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing | Imperative Care, Inc. | 2020 | Class I |
| −1 | K210996 | ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing | Imperative Care, Inc. | 2021 | Class I |
| 0 (this device) | K211476 | ZOOM 71 Reperfusion Catheter; ZOOM Aspiration Tubing | Imperative Care, Inc. | 2021 | — |
| +1 | K243047 | Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration Tubing | Imperative Care, Inc. | 2025 | — |
| +1 | K242672 | Zoom System | Imperative Care, Inc. | 2025 | — |
| +1 | K234083 | Next Generation Aspiration Catheter; Balt Aspiration Tubing Set | Balt USA, LLC | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 2 | 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 |
|---|---|---|---|
| * | K210996 | ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration TubingSummary page 4…NRY Regulation: 21 CFR 870.1250 Manufacturer: Imperative Care Inc. 510(k) #: K210996 D. Device Description: The ZOOMTM 71 Reperfusion Catheter is a single lumen, braid and coil reinforced, variable stiffnes… | 2021 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 Class I)
No FDA recall names this device.
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.
- K210996ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration TubingImperative Care, Inc. · 2021 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K202182ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration TubingImperative Care, Inc. · 2020 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K1830430.071” ID MantaRay Reperfusion Catheter, 0.055” ID MantaRay Reperfusion Catheter, 0.045” ID MantaRay…Imperative Care, Inc. · 2019 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 2 years and passes through 1 company; a new generation was cleared every 8 months on median.
- 3 of the 3 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K243047 (Imperative Care, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K210996.
How does its category compare?
All NRY devicesNRY Catheter, Thrombus Retriever: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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/K211476 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211476: ZOOM 71 Reperfusion Catheter; 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/K211476
Report an extraction error
Are you the manufacturer?
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