Cheen Houng Ent. Co. , Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Cheen Houng Ent. Co. , Ltd.” (first 1997, latest 2013), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 172 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 540 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 2 | 2 |
| BYE | Attachment, Breathing, Positive End Expiratory Pressure | 1 | 1 |
| BYI | Percussor, Powered-Electric | 1 | 1 |
| CBP | Valve, Non-Rebreathing | 1 | 1 |
| KGB | Mask, Oxygen, Non-Rebreathing | 1 | 1 |
Review panels
- Anesthesiology (6)
Most recent Cheen Houng Ent. Co. , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K121587 | BREATH SHAKE | BYI | 2013-11-22 | 540 |
| K021390 | PMX COMPACT RESUCITATOR | BTM | 2002-10-04 | 155 |
| K003927 | Y2000 MANUAL RESUSCITATOR, MODEL RUGU01/RUG02 AND RUGH01/RUGH02 | BTM | 2001-06-26 | 188 |
| K010191 | Y2000 POCKET RESCUE | CBP | 2001-03-14 | 51 |
| K981415 | 0-20 CM H20 PEEP VALVE | BYE | 1998-07-14 | 85 |
| K970688 | POCKET RESCUE | KGB | 1997-09-26 | 213 |
Recalls
openFDA lists no recalls under a recalling firm named Cheen Houng Ent. Co. , Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Cheen Houng Ent. Co. , Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Cheen Houng Ent. Co. , Ltd.” (first 1997, latest 2013), across 5 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Cheen Houng Ent. Co. , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cheen Houng Ent. Co. , Ltd. is 172 days.
Which FDA product codes appear under Cheen Houng Ent. Co. , Ltd.?
The most frequent FDA product codes under this applicant name are BTM (Ventilator, Emergency, Manual (Resuscitator), 2); BYE (Attachment, Breathing, Positive End Expiratory Pressure, 1); BYI (Percussor, Powered-Electric, 1).
Next steps
- See all 6 Cheen Houng Ent. Co. , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code BTM, Cheen Houng Ent. Co. , Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.