510(k) Report

FDA applicant

Trans Aire

Sacramento, CA1 decision1997–19970 recalls

FDA records 1 decision for Trans Aire (Sacramento, CA) in 1997: 1 510(k) clearance. All are in product code EFQ (Gauze/Sponge, Internal). No recall is linked to its devices.

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

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

FDA decisions per year

No FDA decision for Trans Aire since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • EFQGauze/Sponge, Internal1decision

What has FDA decided for it lately?

  • K971178Rand Surgical SpongeTrans Aire · 1997

The one decision as Trans Aire →

Other applicant names beginning “Trans”

FDA records each applicant name separately; these may or may not be the same firm.

Trans Vascular Incorporated 2Trans World Agency, Inc. 2Trans-National Trade Development Corp. 2Trans Texas Medical Devices Corp. 1Trans-America Enterprises Corp. 1Trans-Med Corp. 1Trans American Chemical Corp. 1Trans-Pacific Healthcare-USA 1Trans Ancient Products Co., Ltd. 1Trans-Atlantic Dental 1Trans Pace, Inc. 1