# Q'Apel Medical, Inc.

- Location (FDA's records): Fremont, CA
- FDA decisions: 7 (2019–2026): 7 510(k) clearances
- Names in FDA's records: Q'Apel Medical, Inc. (4); Q'Apel Medical, LLC (1); Q'Apel Medical (1); Q’Apel Medical, Inc. (1)
- Product codes: QJP (3), NRY (2), DQY (2)
- 510(k) review time since 2016: median 128 days, against 139 for FDA's reviews in the same codes and years (5 of 7 faster)
- Predicates its devices cite: 10 (2 its own); citations of its devices by later devices: 2 (2 its own)
- Recalls linked to its devices: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Penumbra, Inc.: 6 (https://510kreport.com/company/penumbra)
- Concentric Medical, Inc.: 1 (https://510kreport.com/company/concentric-medical)
- Q'Apel: 1 (https://510kreport.com/company/q-apel)

## Its most-cited devices
- K211893: SelectFlex Neurovascular Access System Family (2021), cited by 1
- K191664: SelectFlex 072 Neurovascular Access System (2019), cited by 1

## Recent decisions
- K254276: Lynx Aspiration Catheter System (May 7, 2026)
- K240746: Neurovascular Access System Family (Nov 20, 2024)
- K222786: 072 Aspiration System (Aug 25, 2023)
- K230322: SelectFlex Neurovascular Access System Family (Jun 22, 2023)
- K211893: SelectFlex Neurovascular Access System Family (Aug 5, 2021)
- K192525: 087 Balloon Guide Catheter System (Oct 31, 2019)
- K191664: SelectFlex 072 Neurovascular Access System (Aug 30, 2019)

Source page: https://510kreport.com/company/q-apel-medical