Galemed Corp.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Galemed Corp.” (first 2002, latest 2014), across 7 product codes in 2 review panels. Median 510(k) review time under this name: 150 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 | 359 |
| 2014 | 2 | 172 |
| 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) | 1 | 1 |
| BYE | Attachment, Breathing, Positive End Expiratory Pressure | 1 | 1 |
| BZD | Ventilator, Non-Continuous (Respirator) | 1 | 1 |
| BZH | Meter, Peak Flow, Spirometry | 1 | 1 |
| CAF | Nebulizer (Direct Patient Interface) | 1 | 1 |
| CAH | Filter, Bacterial, Breathing-Circuit | 1 | 1 |
| CAP | Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | 1 | 1 |
Review panels
- Anesthesiology (6)
- General Hospital (1)
Most recent Galemed Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K132679 | AF VIRAL/BACTERIAL FILTER, BF VIRAL/BACTERIAL FILTER | CAH | 2014-04-18 | 233 |
| K133957 | DISPOSABLE ADJUSTABLE PEEP VALVE MR CONDITIONAL USE | BYE | 2014-04-14 | 112 |
| K122627 | GIO DIGITAL PRESSURE GUAGES | CAP | 2013-08-22 | 359 |
| K082092 | DISPO-BAG MANUAL RESUSCITATOR, DISPOSABLE ADJUSTABLE PEEP VALVE, DISPOSABLE FIXED PEEP VALVE | BTM | 2008-10-15 | 83 |
| K072755 | GALEMED CPAP MASK | BZD | 2007-11-16 | 50 |
| K022124 | GALEMED PEAK FLOW METER, MODELS 3751/3752 | BZH | 2003-04-03 | 276 |
| K021742 | GALEMED NEB-EASY NEBULIZER | CAF | 2002-10-25 | 150 |
Recalls
3 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2019-05-30.
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 Galemed Corp. (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances are listed under Galemed Corp.?
FDA lists 7 510(k) clearances under the applicant name “Galemed Corp.” (first 2002, latest 2014), across 7 product codes in 2 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 Galemed Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Galemed Corp. is 150 days.
Which FDA product codes appear under Galemed Corp.?
The most frequent FDA product codes under this applicant name are BTM (Ventilator, Emergency, Manual (Resuscitator), 1); BYE (Attachment, Breathing, Positive End Expiratory Pressure, 1); BZD (Ventilator, Non-Continuous (Respirator), 1).
Next steps
- See all 7 Galemed Corp. clearances with predicates and recalls
- Run predicate analysis for product code BTM, Galemed 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.