510(k) Report

FDA applicant

Bolton Medical, Inc.

Sunrise4 decisions2002–20213 recalls

FDA records 4 decisions for Bolton Medical, Inc. (Sunrise) from 2002 to 2021: 1 510(k) clearance and 3 original PMA approvals. Most are in product codes MIH (System, Endovascular Graft, Aortic Aneurysm…) and LIT (Catheter, Angioplasty, Peripheral, Transluminal). Its devices cite 6 predicates, 0 of them its own earlier devices. 3 recalls are linked to its devices, 1 Class I.

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

FDA decisions per year

1in 2021

2012: 12020: 12021: 1
2007high 1 (2012) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2026

2023: 12024: 12026 (partial year): 1, 1 Class I
2007high 1 (2023) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Bolton Medical, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Which product codes does it file in?

  • MIHSystem, Endovascular Graft, Aortic Aneurysm Treatment3decisions
  • LITCatheter, Angioplasty, Peripheral, Transluminal1decision

Whose devices does it build on?

Its devices cite 6 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • P200045RelayPro Thoracic Stent-Graft SystemBolton Medical, Inc. · 20211 Class I recall
  • P190015TREO® Abdominal Stent-Graft SystemBolton Medical, Inc. · 20201 recall
  • P110038Relay Thoracic Stent-Graft with Plus Delivery SystemBolton Medical, Inc. · 2012
  • K021996Bolton Pta CatheterBolton Medical, Inc. · 2002

All 4 as Bolton Medical, Inc. →

What has been recalled?

3 recalls linked to its devices; the latest:

  • P200045RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers: 28-N4-32-104-32U…Apr 22, 2026Class I
  • P200045RELAY PRO Thoracic Stent-Graft System, containing one endovascular stent-graft system…Feb 22, 2024Class II
  • P190015The TREO ABDOMINAL STENT-GRAFT SYSTEM (TREO) consists of four types of implants…May 3, 2023Class II