510(k) Report

FDA applicant

Life Shield Healthcare Products, Inc.

Noblesville, IN17 decisions1993–19930 recalls

FDA records 17 decisions for Life Shield Healthcare Products, Inc. (Noblesville, IN) in 1993: 17 510(k) clearances. Most are in product codes CAI (Circuit, Breathing (W Connector, Adaptor, Y…) and BZO (Set, Tubing And Support, Ventilator (W Harness)). 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, anesthesiology panel, where it files most

How often FDA has decided Life Shield Healthcare Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Life Shield Healthcare Products, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Life Shield Healthcare Products, Inc.’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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