510(k) Report

FDA applicant

Thrombolex, Inc.

New Britain, PA6 decisions2019–20230 recalls

FDA records 6 decisions for Thrombolex, Inc. (New Britain, PA) from 2019 to 2023: 6 510(k) clearances. All are in product code QEY (Mechanical Thrombolysis Catheter). Since 2016 its 510(k)s took a median of 53 days from receipt to decision, against 91 for FDA’s reviews in the same codes and years. Its devices cite 7 predicates, 5 of them its own earlier devices. No recall is linked to its devices.

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 Thrombolex, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2023

2019: 32021: 12023: 2
2019high 3 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

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

Planning a device like Thrombolex, 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?

  • QEYMechanical Thrombolysis Catheter6decisions

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 53 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 91 days; 2 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 7 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 5 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K183290Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200Thrombolex, Inc. · 20195cite it
  • K193071Bashir Plus Endovascular CatheterThrombolex, Inc. · 20191cites it
  • K222095BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101Thrombolex, Inc. · 20231cites it

What has FDA decided for it lately?

  • K231653BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular CatheterThrombolex, Inc. · 2023
  • K222095BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101Thrombolex, Inc. · 2023
  • K211061BASHIR Endovascular Catheter (Ref. 7201), BASHIR Plus 10 Endovascular Catheter (Ref. 7210), BASHIR Plus 20…Thrombolex, Inc. · 2021
  • K193071Bashir Plus Endovascular CatheterThrombolex, Inc. · 2019
  • K192598Bashir S-B Endovascular Catheter, Ref. No. 7101Thrombolex, Inc. · 2019
  • K183290Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200Thrombolex, Inc. · 2019

All 6 as Thrombolex, Inc. →