Southmedic, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Southmedic, Inc.” (first 1984, latest 2023), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 134 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 | 1 | 243 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 459 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Southmedic, Inc. took a median 459 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 249 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CAD | Vaporizer, Anesthesia, Non-Heated | 5 | 5 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 3 | 3 |
| BZA | Connector, Airway (Extension) | 1 | 1 |
| CAF | Nebulizer (Direct Patient Interface) | 1 | 1 |
Review panels
- Anesthesiology (10)
Most recent Southmedic, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K222511 | Oxy2Pro | CCK | 2023-11-21 | 459 |
| K131410 | CO2/O2 NASAL CANNULA (WITH 4 (10CM) O2 AND CO2 TUBE), CO2/O2 NASAL CANNULA (WITH 8 (240CM) O2 AND 4 (10CM) CO2 TUBE), | CCK | 2014-01-13 | 243 |
| K101953 | SMDIA-1000 | CAF | 2011-01-07 | 179 |
| K014211 | OXYARM CO2 | CCK | 2002-06-11 | 172 |
| K945993 | VAPOFIL | CAD | 1995-02-22 | 96 |
| K923265 | FUNNEL ADAPTOR | CAD | 1993-03-18 | 259 |
| K863318 | AEROSOL-T | BZA | 1986-09-11 | 16 |
| K861839 | VAPOFIL | CAD | 1986-05-21 | 8 |
| K860545 | VAPORIZER SPACER | CAD | 1986-04-17 | 63 |
| K843993 | ANAESLOCK THREE VAPORIZER INTERLOCK HVA003 | CAD | 1984-11-15 | 35 |
Recalls
9 product recalls in 6 recall events; 1 initiated in the last five years. Most recent: 2022-10-27.
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 Southmedic, Inc. (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances are listed under Southmedic, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Southmedic, Inc.” (first 1984, latest 2023), across 4 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 Southmedic, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Southmedic, Inc. is 134 days.
Which FDA product codes appear under Southmedic, Inc.?
The most frequent FDA product codes under this applicant name are CAD (Vaporizer, Anesthesia, Non-Heated, 5); CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, 3); BZA (Connector, Airway (Extension), 1).
Next steps
- See all 10 Southmedic, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CAD, Southmedic, Inc.'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.