510(k) · Cleared
ClearedNext Generation Aspiration Catheter; Balt Aspiration Tubing Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Balt USA, LLC · NRY Catheter, Thrombus Retriever
Cleared on Jul 2, 2024 as substantially equivalent to K211476 (Imperative Care, Inc., 2021) after a 193-day review. Its family tree reaches back 4 generations to 2019. 3 of the 5 devices in its family, counting itself, have a Class I recall.
- Decided
- Jul 2, 2024
- Review
- 193 days
- Class
- Class II
- Product code
- NRY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K183043 (2019). No later device cites it as a predicate yet. 3 of the 5 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK183043 0.071” ID MantaRay Reperfusion Catheter, 0.055” ID MantaRay…Imperative Care, Inc. · 2019 · Recalled (Class I)
- 3 generations backK202182 ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration TubingImperative Care, Inc. · 2020 · Recalled (Class I)
- 2 generations backK210996 ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration TubingImperative Care, Inc. · 2021 · Recalled (Class I)
- 1 generation backK211476 ZOOM 71 Reperfusion Catheter; ZOOM Aspiration TubingImperative Care, Inc. · 2021
- This deviceK234083 Next Generation Aspiration Catheter; Balt Aspiration Tubing SetBalt USA, LLC · 2024
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K183043 | 0.071” ID MantaRay Reperfusion Catheter, 0.055” ID MantaRay Reperfusion… | Imperative Care, Inc. | 2019 | Class I |
| −3 | K202182 | ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing | Imperative Care, Inc. | 2020 | Class I |
| −2 | K210996 | ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing | Imperative Care, Inc. | 2021 | Class I |
| −1 | K211476 | ZOOM 71 Reperfusion Catheter; ZOOM Aspiration Tubing | Imperative Care, Inc. | 2021 | — |
| 0 (this device) | K234083 | Next Generation Aspiration Catheter; Balt Aspiration Tubing Set | Balt USA, LLC | 2024 | — |
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 |
|---|---|---|---|
| * | K211476 | ZOOM 71 Reperfusion Catheter; ZOOM Aspiration TubingSummary page 4…heter Device Classification: Class II Predicate Device: ZOOM 71 Reperfusion Catheter; ZOOM Aspiration Tubing 510(k)#: K211476 Device Description: The Next Generation Aspiration Catheter is a single-lumen, coil reinforced, variable stiffness composite cat… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K202182ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration TubingImperative Care, Inc. · 2020 · 3 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 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
- 3 of the 4 ancestors have a recall of any class; 3 have a Class I recall.
- 2 other devices also cite its predicate K211476.
How does its category compare?
All NRY devicesNRY Catheter, Thrombus Retriever: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
Next Generation Aspiration Catheter: The Next Generation Aspiration Catheter with a compatible aspiration pump and Balt Aspiration Tubing Set is 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…
Read the full statement (115 words)
Next Generation Aspiration Catheter:
The Next Generation Aspiration Catheter with a compatible aspiration pump and Balt Aspiration Tubing Set is 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-tPA) or who fail IV-tPA therapy are candidates for treatment.
Balt Aspiration Tubing Set:
The Balt Aspiration Tubing Set is intended to connect the Next Generation Aspiration Catheter to the canister of a compatible aspiration pump and to allow the user to control the fluid flow.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K234083 · printed Nov 4, 2026
Cite this page
510(k) Report. “K234083: Next Generation Aspiration Catheter; Balt Aspiration Tubing Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K234083
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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