510(k) Report

FDA applicant

Q'Apel Medical, Inc.

Fremont, CA7 decisions2019–20261 recall

FDA records 7 decisions for Q'Apel Medical, Inc. (Fremont, CA) from 2019 to 2026: 7 510(k) clearances. Most are in product codes QJP (Catheter, Percutaneous, Neurovasculature) and NRY (Catheter, Thrombus Retriever). Since 2016 its 510(k)s took a median of 128 days from receipt to decision, against 139 for FDA’s reviews in the same codes and years. Its devices cite 10 predicates, 2 of them its own earlier devices. 1 recall is linked to its devices, 1 Class I.

FDA’s records also spell it “Q'Apel Medical, LLC”, “Q'Apel Medical”, “Q’Apel Medical, Inc.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Q'Apel Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2019: 22021: 12023: 22024: 12026 (partial year): 1
2019high 2 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

1in 2025

2025: 1, 1 Class I
2019high 1 (2025) · low 0 (2019)2026

Class I Class II/III not classified

FIG. 1 — Q'Apel Medical, Inc. by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Q'Apel Medical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • QJPCatheter, Percutaneous, Neurovasculature3decisions
  • NRYCatheter, Thrombus Retriever2decisions
  • DQYCatheter, Percutaneous2decisions

How long do its 510(k) reviews take?

Since 2016, its 7 510(k)s took a median of 128 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 139 days; 5 of its 7 were faster than that.

Whose devices does it build on?

Its devices cite 10 predicates; 2 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K211893SelectFlex Neurovascular Access System FamilyQ'Apel Medical, Inc. · 20211cites it
  • K191664SelectFlex 072 Neurovascular Access SystemQ'Apel Medical · 20191cites it

What has FDA decided for it lately?

  • K254276Lynx Aspiration Catheter SystemQ’Apel Medical, Inc. · 2026
  • K240746Neurovascular Access System FamilyQ'Apel Medical, Inc. · 2024
  • K222786072 Aspiration SystemQ'Apel Medical, Inc. · 20231 Class I recall
  • K230322SelectFlex Neurovascular Access System FamilyQ'Apel Medical, Inc. · 2023
  • K211893SelectFlex Neurovascular Access System FamilyQ'Apel Medical, Inc. · 2021
  • K192525087 Balloon Guide Catheter SystemQ'Apel Medical, LLC · 2019
  • K191664SelectFlex 072 Neurovascular Access SystemQ'Apel Medical · 2019

All 4 as Q'Apel Medical, Inc. →The one decision as Q'Apel Medical, LLC →The one decision as Q'Apel Medical →

What has been recalled?

1 recall linked to its devices; the latest:

  • K222786Hippo 072 Aspiration System including Cheetah Delivery Tool and Aspiration Tubing, REF…Feb 26, 2025Class I