510(k) Report

FDA applicant

Shanghai Little Doctor Co. Limited

Nantong, Jiangsu, CN2 decisions2009–20090 recalls

FDA records 2 decisions for Shanghai Little Doctor Co. Limited (Nantong, Jiangsu, CN) in 2009: 2 510(k) clearances. All are in product code DXN (System, Measurement, Blood-Pressure…). Its devices cite 2 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, cardiovascular panel, where it files most

How often FDA has decided Shanghai Little Doctor Co. Limited’s devices, and how often a recall has named them.

FDA decisions per year

2in 2009

2009: 2
2009high 2 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Shanghai Little Doctor Co. Limited by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Shanghai Little Doctor Co. Limited’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

Which product codes does it file in?

  • DXNSystem, Measurement, Blood-Pressure, Non-Invasive2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K0933591103 Digital Blood Pressure Monitor, Model LD 1103, 1133 Digital Blood Pressure Monitor, Model LD 1133Shanghai Little Doctor Co. Limited · 2009
  • K092683Digital Wrist Blood Pressure Monitor, Model LD 1143Shanghai Little Doctor Co. Limited · 2009

All 2 as Shanghai Little Doctor Co. Limited →