510(k) Report

FDA applicant

Colin Medical Instruments Corp.

San Antonio, TX15 decisions1986–20040 recalls

FDA records 15 decisions for Colin Medical Instruments Corp. (San Antonio, TX) from 1986 to 2004: 15 510(k) clearances. Most are in product codes DXN (System, Measurement, Blood-Pressure…) and DQA (Oximeter). Its devices cite 11 predicates, 10 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, cardiovascular panel, where it files most

How often FDA has decided Colin Medical Instruments Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Colin Medical Instruments Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Colin Medical Instruments Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Colin”

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