510(k) Report

FDA applicant

Shenzhen Homed Medical Device Co., Ltd.

Shenzhen, CN4 decisions2017–20250 recalls

FDA records 4 decisions for Shenzhen Homed Medical Device Co., Ltd. (Shenzhen, CN) from 2017 to 2025: 4 510(k) clearances. Most are in product codes CAF (Nebulizer (Direct Patient Interface)) and CAW (Generator, Oxygen, Portable). Since 2016 its 510(k)s took a median of 343 days from receipt to decision, against 177 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 0 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, anesthesiology panel, where it files most

How often FDA has decided Shenzhen Homed Medical Device Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2017: 12018: 12022: 12025: 1
2017high 1 (2017) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Shenzhen Homed Medical Device Co., Ltd. by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Shenzhen Homed Medical Device Co., Ltd.’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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Which product codes does it file in?

  • CAFNebulizer (Direct Patient Interface)3decisions
  • CAWGenerator, Oxygen, Portable1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 343 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 177 days; 1 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K252616Portable oxygen concentrator (JLO-190P)Shenzhen Homed Medical Device Co., Ltd. · 2025
  • K212395NebulizerShenzhen Homed Medical Device Co., Ltd. · 2022
  • K170886HOMED Mesh NebulizerShenzhen Homed Medical Device Co., Ltd. · 2018
  • K161586The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS)Shenzhen Homed Medical Device Co., Ltd. · 2017

All 4 as Shenzhen Homed Medical Device Co., Ltd. →