510(k) Report

FDA applicant

Water-Jel Technologies, Inc.

Carlstadt, NJ2 decisions1995–20010 recalls

FDA records 2 decisions for Water-Jel Technologies, Inc. (Carlstadt, NJ) from 1995 to 2001: 2 510(k) clearances. Most are in product codes LRR (First Aid Kit With Drug) and MGQ (Dressing, Wound And Burn, Hydrogel W/Drug…). No recall is linked to its devices.

FDA’s records also spell it “Water-Jel Technologies, LLC”.

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

How often FDA has decided Water-Jel Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Water-Jel Technologies, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Water-Jel Technologies, 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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Other applicant names beginning “Water-Jel”

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