ULTRAMIST 2000— 510(k) K972657

Name: FDA 510(k) clearance K972657
Creator: U.S. Food and Drug Administration
Published: 1998-02-02

Substantially Equivalent

Texas Medical Industries, Inc.

FDA 510(k) clearance K972657 for ULTRAMIST 2000, Substantially Equivalent on 1998-02-02. Applicant: Texas Medical Industries, Inc.. Device class: 2.

Clearance details

Applicant: Texas Medical Industries, Inc.
Product code: Code CAF
Device class: Class 2
Regulation: 21 CFR 868.5630
Advisory panel: Anesthesiology
Date received: 1997-07-15
Decision date: 1998-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Royse City, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CAF

view all

K260270 — FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)2026-06-02
K251572 — eRapid with eTrack System2025-12-19
K251659 — Mesh Nebulizer (H6)2025-11-14
K244035 — Portable mesh nebulizer (JM821)2025-09-19
K243468 — Compressor Nebulizer (4 models)2025-07-02

Adverse events under product code CAF

product code CAF

Death: 22
Injury: 125
Malfunction: 613
Other: 11
Total: 771

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.