Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Chartermed, Inc. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K973103 | CHARTERMED TPN-EVA BAGS | Chartermed, Inc. | 1997-11-24 | 97 | 0 |
| K902079 | ADMIXTURE CONTAINER FOR TOTAL PARENTERAL NUTRITION | Chartermed, Inc. | 1990-10-29 | 174 | 0 |
| K902464 | CHARTERMED EMPTY TPN CONTAINER - 100 ML CAPACITY | Chartermed, Inc. | 1990-08-30 | 87 | 0 |
| K901753 | 600 OR 1200 ML. ENTERAL BAG ADMINISTRATION SET | Chartermed, Inc. | 1990-06-01 | 46 | 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