Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cheen Houng Ent. Co. , Ltd. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
188 daysmedian FDA review time
540 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K121587 | BREATH SHAKE | Cheen Houng Ent. Co. , Ltd. | 2013-11-22 | 540 | 0 |
| K021390 | PMX COMPACT RESUCITATOR | Cheen Houng Ent. Co. , Ltd. | 2002-10-04 | 155 | 0 |
| K003927 | Y2000 MANUAL RESUSCITATOR, MODEL RUGU01/RUG02 AND RUGH01/RUG | Cheen Houng Ent. Co. , Ltd. | 2001-06-26 | 188 | 0 |
| K010191 | Y2000 POCKET RESCUE | Cheen Houng Ent. Co. , Ltd. | 2001-03-14 | 51 | 0 |
| K981415 | 0-20 CM H20 PEEP VALVE | Cheen Houng Ent. Co. , Ltd. | 1998-07-14 | 85 | 0 |
| K970688 | POCKET RESCUE | Cheen Houng Ent. Co. , Ltd. | 1997-09-26 | 213 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda