510(k) Report

FDA applicant

Dalian Labtek Science & Development Co., Ltd.

Shanghai, CN3 decisions2012–20220 recalls

FDA records 3 decisions for Dalian Labtek Science & Development Co., Ltd. (Shanghai, CN) from 2012 to 2022: 3 510(k) clearances. All are in product code JOW (Sleeve, Limb, Compressible). Its devices cite 2 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, cardiovascular panel, where it files most

How often FDA has decided Dalian Labtek Science & Development Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2012: 12013: 12022: 1
2012high 1 (2012) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Dalian Labtek Science & Development Co., Ltd. by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Dalian Labtek Science & Development…’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?

  • JOWSleeve, Limb, Compressible3decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K123830Intermittent Pneumatic Compression DeviceDalian Labtek Science & Development Co., Ltd. · 20132cite it

What has FDA decided for it lately?

  • K213313Veinoflow SCD (Model: LBTK-M-I 5006)Dalian Labtek Science & Development Co., Ltd. · 2022
  • K123830Intermittent Pneumatic Compression DeviceDalian Labtek Science & Development Co., Ltd. · 2013
  • K121718A-V Foot PumpDalian Labtek Science & Development Co., Ltd. · 2012

All 3 as Dalian Labtek Science & Development Co., Ltd. →