Q'apel Medical, Inc.
Fremont, CA, US
Q'apel Medical, Inc. appears in FDA device records in Fremont, CA. FDA records list 7 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 7 510(k) clearances for Q'apel Medical, Inc. between 2019 and 2026. The busiest year on record is 2019, with 2. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2019 | 2 |
| 2021 | 1 |
| 2023 | 2 |
| 2024 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K254276 | Lynx Aspiration Catheter System | NRY | Substantially Equivalent | |
| K240746 | Neurovascular Access System Family | QJP | Substantially Equivalent | |
| K222786 | 072 Aspiration System | NRY | Substantially Equivalent | |
| K230322 | SelectFlex Neurovascular Access System Family | QJP | Substantially Equivalent | |
| K211893 | SelectFlex Neurovascular Access System Family | QJP | Substantially Equivalent | |
| K192525 | 087 Balloon Guide Catheter System | DQY | Substantially Equivalent | |
| K191664 | SelectFlex 072 Neurovascular Access System | DQY | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3020954126 | 3020954126 | Q'apel Medical, Inc. | 4245 Technology Drive, Fremont, CA 94538 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1512-2025 | Hippo 072 Aspiration System including Cheetah Delivery Tool and Aspiration Tubing, REF: APT6072-132. Hippo 072 Aspiration System including Cheetah Delivery Tool, REF: AP6072-132. 072 Aspiration Tubing, REF: APT-95 | Aspiration catheter distal tip features and characteristics may not be in the scope of FDA clearance; tip detachment, vessel rupture, and vasospasm could occur. | Class I | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain