Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Swartz Medical Equipment · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
21 daysmedian FDA review time
25 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K771501 | ANEROID SPHYGMOMETER | Swartz Medical Equipment | 1977-08-30 | 25 | 0 |
| K771502 | ANEROID SPHYGMOMETER | Swartz Medical Equipment | 1977-08-30 | 25 | 0 |
| K771505 | STETHOSCOPE | Swartz Medical Equipment | 1977-08-26 | 21 | 0 |
| K771506 | STETHOSCOPE | Swartz Medical Equipment | 1977-08-26 | 21 | 0 |
| K771504 | STETHOSCOPE | Swartz Medical Equipment | 1977-08-26 | 21 | 0 |
| K771581 | STETHOSCOPE, NURSESCOPE TYPE | Swartz Medical Equipment | 1977-08-26 | 8 | 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