Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Southmedic, Inc. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
172 daysmedian FDA review time
459 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K222511 | Oxy2Pro | Southmedic, Inc. | 2023-11-21 | 459 | 0 |
| K131410 | CO2/O2 NASAL CANNULA (WITH 4 (10CM) O2 AND CO2 TUBE), CO2/O2 | Southmedic, Inc. | 2014-01-13 | 243 | 0 |
| K101953 | SMDIA-1000 | Southmedic, Inc. | 2011-01-07 | 179 | 0 |
| K014211 | OXYARM CO2 | Southmedic, Inc. | 2002-06-11 | 172 | 1 |
| K945993 | VAPOFIL | Southmedic, Inc. | 1995-02-22 | 96 | 2 |
| K923265 | FUNNEL ADAPTOR | Southmedic, Inc. | 1993-03-18 | 259 | 0 |
| K863318 | AEROSOL-T | Southmedic, Inc. | 1986-09-11 | 16 | 0 |
| K861839 | VAPOFIL | Southmedic, Inc. | 1986-05-21 | 8 | 0 |
| K860545 | VAPORIZER SPACER | Southmedic, Inc. | 1986-04-17 | 63 | 0 |
| K843993 | ANAESLOCK THREE VAPORIZER INTERLOCK HVA003 | Southmedic, Inc. | 1984-11-15 | 35 | 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