510(k) Report

FDA applicant

Isovac Products, LLC

Bellaire, TX2 decisions2006–20170 recalls

FDA records 2 decisions for Isovac Products, LLC (Bellaire, TX) from 2006 to 2017: 2 510(k) clearances. Most are in product codes LGN (Chamber, Patient Transport Isolation) and LGM (Chamber, Patient Isolation). Its devices cite 2 predicates, 1 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, general hospital panel, where it files most

How often FDA has decided Isovac Products, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2017: 1
2007high 1 (2017) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Isovac Products, LLC’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?

  • LGNChamber, Patient Transport Isolation1decision
  • LGMChamber, Patient Isolation1decision

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • K052798Capsuls, Models 2003-PUR8C, 2004-PVC8CIsovac Products, LLC · 20062cite it

What has FDA decided for it lately?

  • K163223ORCA (tm) - Operational Rescue Containment ApparatusIsovac Products, LLC · 2017
  • K052798Capsuls, Models 2003-PUR8C, 2004-PVC8CIsovac Products, LLC · 2006

All 2 as Isovac Products, LLC →