510(k) Report

FDA applicant

Insightra Medical

Irvine, CA4 decisions2009–20151 recall

FDA records 4 decisions for Insightra Medical (Irvine, CA) from 2009 to 2015: 4 510(k) clearances. Most are in product codes FTL (Mesh, Surgical, Polymeric) and DSP (System, Balloon, Intra-Aortic And Control). Its devices cite 9 predicates, 1 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Insightra Medical, Inc.”.

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

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Insightra Medical’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2009: 12012: 12014: 12015: 1
2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

1in 2025

2025: 1
2009high 1 (2025) · low 0 (2009)2026

Class I Class II/III not classified

FIG. 1 — Insightra Medical by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Insightra Medical’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?

  • FTLMesh, Surgical, Polymeric3decisions
  • DSPSystem, Balloon, Intra-Aortic And Control1decision

Whose devices does it build on?

Its devices cite 9 predicates; 1 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.

  • K113552Freedom Inguinal Hernia ImplantInsightra Medical · 20121cites it

What has FDA decided for it lately?

  • K142192Insightra Freedom Ventral Hernia Repair SystemInsightra Medical · 2015
  • K140967Freedom Inguinal Hernia Repair Implant-25MM/40MM/40MM with Extended DiskInsightra Medical · 2014
  • K113552Freedom Inguinal Hernia ImplantInsightra Medical · 2012
  • K082746Ultra Iabp Catheter Kit, Models IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, IMU7F-20Insightra Medical, Inc. · 20091 recall

All 3 as Insightra Medical →The one decision as Insightra Medical, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K082746Brand Name: Ultra IABP Catheter Kit Product Name: Ultra IABP Catheter Kit Model/Catalog…Jul 19, 2025Class II