FDA applicant

Healthy.Io, Ltd.

Tel Aviv, IL4 decisions2018–20230 recalls

FDA records 4 decisions for Healthy.Io, Ltd. (Tel Aviv, IL) from 2018 to 2023: 4 510(k) clearances. Most are in product codes JIR (Indicator Method, Protein Or Albumin (Urinary…) and JFY (Enzymatic Method, Creatinine). Its devices cite 4 predicates, 1 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, clinical chemistry panel, where it files most

How often FDA has decided Healthy.Io, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2018high 1 (2018) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Healthy.Io, Ltd. by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Other applicant names beginning “Healthy.Io”

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

Healthy Glove Co., Ltd. 2 Healthy Sleep Dental Laboratory 1

Healthy.Io, Ltd.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Healthy.Io”