510(k) Report

FDA applicant

Cheen Houng Ent. Co., Ltd.

Taipei (Shulin), TW6 decisions1997–20130 recalls

FDA records 6 decisions for Cheen Houng Ent. Co., Ltd. (Taipei (Shulin), TW) from 1997 to 2013: 6 510(k) clearances. Most are in product codes BTM (Ventilator, Emergency, Manual (Resuscitator)) and CBP (Valve, Non-Rebreathing). 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 Cheen Houng Ent. Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2013: 1
2007high 1 (2013) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • BTMVentilator, Emergency, Manual (Resuscitator)2decisions
  • CBPValve, Non-Rebreathing1decision
  • BYIPercussor, Powered-Electric1decision
  • KGBMask, Oxygen, Non-Rebreathing1decision
  • BYEAttachment, Breathing, Positive End Expiratory Pressure1decision

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K9814150-20 CM H20 Peep ValveCheen Houng Ent. Co., Ltd. · 19981cites it

What has FDA decided for it lately?

  • K121587Breath ShakeCheen Houng Ent. Co., Ltd. · 2013
  • K021390PMX Compact ResucitatorCheen Houng Ent. Co., Ltd. · 2002
  • K003927Y2000 Manual Resuscitator, Model RUGU01/RUG02 and RUGH01/RUGH02Cheen Houng Ent. Co., Ltd. · 2001
  • K010191Y2000 Pocket RescueCheen Houng Ent. Co., Ltd. · 2001
  • K9814150-20 CM H20 Peep ValveCheen Houng Ent. Co., Ltd. · 1998
  • K970688Pocket RescueCheen Houng Ent. Co., Ltd. · 1997

All 6 as Cheen Houng Ent. Co., Ltd. →