Besmed Health Business Corp: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Besmed Health Business Corp” (first 2003, latest 2024), across 9 product codes in 4 review panels. Median 510(k) review time under this name: 115 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 | 0 | — |
| 2014 | 3 | 105 |
| 2015 | 2 | 104 |
| 2016 | 1 | 101 |
| 2017 | 0 | — |
| 2018 | 1 | 115 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 185 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Besmed Health Business Corp took a median 150 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 221 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| BWF | Spirometer, Therapeutic (Incentive) | 2 | 2 |
| CAF | Nebulizer (Direct Patient Interface) | 2 | 2 |
| BYE | Attachment, Breathing, Positive End Expiratory Pressure | 1 | 1 |
| BZH | Meter, Peak Flow, Spirometry | 1 | 1 |
| CAH | Filter, Bacterial, Breathing-Circuit | 1 | 1 |
| CAP | Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | 1 | 1 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 1 | 1 |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 1 | 1 |
| IPF | Stimulator, Muscle, Powered | 1 | 1 |
Review panels
- Anesthesiology (8)
- General Hospital (1)
- Neurology (1)
- Physical Medicine (1)
Most recent Besmed Health Business Corp 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K241339 | Besmed Bacterial Filter and HMEF | CAH | 2024-11-14 | 185 |
| K172804 | Besmed Peak Flow Meter | BZH | 2018-01-11 | 115 |
| K160112 | Besmed PEEP Valve | BYE | 2016-04-29 | 101 |
| K150591 | Besmed Reusable Jet Nebulizer | CAF | 2015-06-30 | 113 |
| K143150 | CO2 monitoring line with and without in-line filter | CCK | 2015-02-05 | 94 |
| K141355 | VOLUMETRIC INCENTIVE SPIROMETER | BWF | 2014-09-03 | 103 |
| K140370 | DISPOSABLE PRESSURE MANOMETER | CAP | 2014-06-19 | 125 |
| K133873 | TRIBALL INCENTIVE SPIROMETER | BWF | 2014-04-04 | 105 |
| K091272 | BESMED JET NEBULIZER BOTTLE SET | CAF | 2009-11-10 | 194 |
| K031374 | BESMED VARIOUS MODELS OF TENS, BE-550/BE-660 | GZJ | 2003-11-28 | 212 |
1 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2018-08-09.
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Besmed Health Business Corp (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances are listed under Besmed Health Business Corp?
FDA lists 11 510(k) clearances under the applicant name “Besmed Health Business Corp” (first 2003, latest 2024), across 9 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Besmed Health Business Corp?
The median time from FDA receipt to decision across 510(k)s cleared under the name Besmed Health Business Corp is 115 days.
Which FDA product codes appear under Besmed Health Business Corp?
The most frequent FDA product codes under this applicant name are BWF (Spirometer, Therapeutic (Incentive), 2); CAF (Nebulizer (Direct Patient Interface), 2); BYE (Attachment, Breathing, Positive End Expiratory Pressure, 1).
Next steps
- See all 11 Besmed Health Business Corp clearances with predicates and recalls
- Run predicate analysis for product code BWF, Besmed Health Business Corp'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.