Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
United Medical Systems, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
145 daysmedian FDA review time
148 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K072538 | PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPTER | United Medical Systems, Inc. | 2008-01-30 | 145 | 0 |
| K032958 | PIEZOLITH 3000 LITHOTRIPTER, MODEL 3000 | United Medical Systems, Inc. | 2004-02-17 | 148 | 0 |
| K894949 | SQA | United Medical Systems, Inc. | 1989-12-29 | 148 | 0 |
| K893003 | TOCOLYTIC SITE CARE SUP KIT #1001/100A/CARRY CASE | United Medical Systems, Inc. | 1989-07-14 | 81 | 0 |
| K863645 | SCHULMAN DOUBLE UMBILICAL CORD CLAMP NO. 1000 | United Medical Systems, Inc. | 1986-09-25 | 7 | 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