510(k) Report

FDA applicant

Life-Tech Intl., Inc.

Houston, TX68 decisions1982–20001 recall

FDA records 68 decisions for Life-Tech Intl., Inc. (Houston, TX) from 1982 to 2000: 68 510(k) clearances. Most are in product codes FAP (Cystometric Gas (Carbon-Dioxide) On Hydraulic…) and FEN (Device, Cystometric, Hydraulic). 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, gastroenterology and urology panel, where it files most

How often FDA has decided Life-Tech Intl., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Life-Tech Intl., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Life-Tech Intl., Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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