Data / Medical devices / United States / Q'apel Medical, Inc.

Q'apel Medical, Inc.: FDA-registered device maker in Fremont, CA, United States, 5 510(k) clearances

Name: Q'apel Medical, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Q'apel Medical, Inc. is registered with the FDA (registration 3020954126) in Fremont, CA, United States. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated May 7, 2026. 1 recall event names it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3020954126
Address: 4245 Technology Drive, Fremont, CA, United States, 94538
Owner or operator: Q'Apel Medical Inc. (10058467)
Roles: Manufacturer
First device listed: August 9, 2019
Registered through: 2026
Brand names listed: 087 Balloon Guide Catheter System, Armadillo, Lynx Aspiration Catheter System, Neurovascular Access System Family, SelectFlex Neurovascular Access System Family, Walrus, Zebra

Devices it lists

Device	Product code	Class	Role	Source
Catheter, Percutaneous	DQY	2	Manufacturer	accessdata.fda.gov
Catheter, Percutaneous, Neurovasculature	QJP	2	Manufacturer	accessdata.fda.gov
Catheter, Thrombus Retriever	NRY	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
May 7, 2026	K254276	Lynx Aspiration Catheter System	NRY	Substantially Equivalent	QApel Medical, Inc.	accessdata.fda.gov
November 20, 2024	K240746	Neurovascular Access System Family	QJP	Substantially Equivalent	Q'Apel Medical, Inc.	accessdata.fda.gov
August 5, 2021	K211893	SelectFlex Neurovascular Access System Family	QJP	Substantially Equivalent	Q'Apel Medical, Inc.	accessdata.fda.gov
October 31, 2019	K192525	087 Balloon Guide Catheter System	DQY	Substantially Equivalent	Q'Apel Medical, LLC	accessdata.fda.gov
July 15, 2019	K190749	087 Balloon Guide Catheter System	DQY	Substantially Equivalent	Q'Apel	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
February 26, 2025	96492	Class I	Ongoing	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.	accessdata.fda.gov

Compare with other makers

Updated May 7, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.