510(k) Report

FDA applicant

Bam Corp., Ltd.

Kowloon, HK4 decisions1994–20170 recalls

FDA records 4 decisions for Bam Corp., Ltd. (Kowloon, HK) from 1994 to 2017: 4 510(k) clearances. Most are in product codes FXX (Mask, Surgical) and FYA (Gown, Surgical). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Bam Corporation Limited”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Bam Corp., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2011: 12017: 1
2007high 1 (2011) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Bam Corp., Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Bam Corp., Ltd.’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?

  • FXXMask, Surgical2decisions
  • FYAGown, Surgical1decision
  • QPCGown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection1decision

Whose devices does it build on?

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

Who builds on its devices?

Later devices cite its devices 3 times; 0 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.

  • K160337Safecare Open Back Protective Gowns and ValueCare Open Back Protective GownsBam Corporation Limited · 20173cite it

What has FDA decided for it lately?

  • K160337Safecare Open Back Protective Gowns and ValueCare Open Back Protective GownsBam Corporation Limited · 2017
  • K093835Bam Standard Surgical Gown, Bam Reinforced Surgical Gown, Bam Ultra Reinforced Surgical GownBam Corp., Ltd. · 2011
  • K933748Surgical Face Masks Plus Anti-Fog ShieldBam Corp., Ltd. · 1994
  • K931580Disposable Surgical Mask (Modified)Bam Corp., Ltd. · 1994

All 3 as Bam Corp., Ltd. →The one decision as Bam Corporation Limited →