Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Besmed Health Business Corp · Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
125 daysmedian FDA review time
212 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K241339 | Besmed Bacterial Filter and HMEF | Besmed Health Business Corp | 2024-11-14 | 185 | 0 |
| K172804 | Besmed Peak Flow Meter | Besmed Health Business Corp | 2018-01-11 | 115 | 0 |
| K160112 | Besmed PEEP Valve | Besmed Health Business Corp | 2016-04-29 | 101 | 0 |
| K150591 | Besmed Reusable Jet Nebulizer | Besmed Health Business Corp | 2015-06-30 | 113 | 0 |
| K143150 | CO2 monitoring line with and without in-line filter | Besmed Health Business Corp | 2015-02-05 | 94 | 0 |
| K140370 | DISPOSABLE PRESSURE MANOMETER | Besmed Health Business Corp | 2014-06-19 | 125 | 0 |
| K133873 | TRIBALL INCENTIVE SPIROMETER | Besmed Health Business Corp | 2014-04-04 | 105 | 0 |
| K091272 | BESMED JET NEBULIZER BOTTLE SET | Besmed Health Business Corp | 2009-11-10 | 194 | 0 |
| K031374 | BESMED VARIOUS MODELS OF TENS, BE-550/BE-660 | Besmed Health Business Corp | 2003-11-28 | 212 | 0 |
| K031375 | BESMED VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, BE-560/B | Besmed Health Business Corp | 2003-11-20 | 204 | 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