Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Integrated Medical Systems, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
58 daysmedian FDA review time
164 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K082256 | LIFE SUPPORT FOR TRAUMA AND TRNSPORT (LSTAT) G6 LITE | Integrated Medical Systems, Inc. | 2008-09-26 | 49 | 0 |
| K902682 | STICK-GARD STERILE CAP | Integrated Medical Systems, Inc. | 1990-09-26 | 99 | 0 |
| K895414 | MULTIMED (TM) PULMONARY FUNCTION TESTING SYSTEM | Integrated Medical Systems, Inc. | 1990-02-12 | 164 | 0 |
| K871659 | IMS-2000S STRESS MONITOR | Integrated Medical Systems, Inc. | 1987-05-28 | 30 | 0 |
| K870934 | IMS-2000R RESTING ELECTROCARDIOGRAPHIC SYSTEM | Integrated Medical Systems, Inc. | 1987-05-06 | 58 | 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