510(k) Report

FDA applicant

Zhongshan A&J Medical Equipment Co., Ltd.

Guangdong, CN4 decisions2007–20260 recalls

FDA records 4 decisions for Zhongshan A&J Medical Equipment Co., Ltd. (Guangdong, CN) from 2007 to 2026: 4 510(k) clearances. Most are in product codes CAW (Generator, Oxygen, Portable) and BTA (Pump, Portable, Aspiration (Manual Or Powered)). 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, anesthesiology panel, where it files most

How often FDA has decided Zhongshan A&J Medical Equipment Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2007: 12008: 12012: 12026 (partial year): 1
2007high 1 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Zhongshan A&J Medical Equipment Co., Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Zhongshan A&J Medical Equipment Co.…’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?

  • CAWGenerator, Oxygen, Portable2decisions
  • BTAPump, Portable, Aspiration (Manual Or Powered)1decision
  • ITIWheelchair, Powered1decision

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 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.

  • K071608A&J POCA01 Oxygen ConcentratorZhongshan A&J Medical Equipment Co., Ltd. · 20084cite it

What has FDA decided for it lately?

  • K253340Electric Wheelchair (AL-208S-063)Zhongshan A&J Medical Equipment Co., Ltd. · 2026
  • K121531A&J 5L Poca Series Oxygen ConcentratorZhongshan A&J Medical Equipment Co., Ltd. · 2012
  • K071608A&J POCA01 Oxygen ConcentratorZhongshan A&J Medical Equipment Co., Ltd. · 2008
  • K071607ASA01 Heavy Duty Suction PumpZhongshan A&J Medical Equipment Co., Ltd. · 2007

All 4 as Zhongshan A&J Medical Equipment Co., Ltd. →