510(k) Report

FDA applicant

Neomend, Inc.

Irvine2 decisions2010–20161 recall

FDA records 2 decisions for Neomend, Inc. (Irvine) from 2010 to 2016: 2 original PMA approvals. All are in product code NBE (Sealant, Polymerizing). 1 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 Neomend, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2010: 12016: 1
2010high 1 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

1in 2012

2012: 1
2010high 1 (2012) · low 0 (2010)2026

Class I Class II/III not classified

FIG. 1 — Neomend, Inc. by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Neomend, 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?

  • NBESealant, Polymerizing2decisions

What has FDA decided for it lately?

  • P150016Tridyne Vascular SealantNeomend, Inc. · 2016
  • P010047Progel Pleural Air Leak SealantNeomend, Inc. · 20101 recall

All 2 as Neomend, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • P010047Progel Pleural Air Leak Sealant, Model #: PGPS002 Lot #: 111202-002 Product Usage: The…Aug 13, 2012Class II