510(k) Report

FDA applicant

Shenzhen Pacom Medical Instruments Co., Ltd.

Shenzhen, CN2 decisions2018–20190 recalls

FDA records 2 decisions for Shenzhen Pacom Medical Instruments Co., Ltd. (Shenzhen, CN) from 2018 to 2019: 2 510(k) clearances. All are in product code FLL (Continuous Measurement Thermometer). Its devices cite 1 predicate, 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, general hospital panel, where it files most

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

FDA decisions per year

1in 2019

2018: 12019: 1
2018high 1 (2018) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Shenzhen Pacom Medical Instruments Co., Ltd. by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Shenzhen Pacom Medical Instruments…’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?

  • FLLContinuous Measurement Thermometer2decisions

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K190717Infrared Thermometer, model: PC808Shenzhen Pacom Medical Instruments Co., Ltd. · 2019
  • K172889Infrared ThermometerShenzhen Pacom Medical Instruments Co., Ltd. · 2018

All 2 as Shenzhen Pacom Medical Instruments Co., Ltd. →