Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Chathamborough Research Group, 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) |
|---|---|---|---|---|---|
| K915676 | SPLATTER SHIELD | Chathamborough Research Group, Inc. | 1992-09-11 | 267 | 0 |
| K904906 | SHARPOINT POLYPROPYLENE NONABSORB SURG SUTURES USP | Chathamborough Research Group, Inc. | 1990-12-24 | 60 | 0 |
| K902309 | PARKER MICROPUMP MODEL 2100 | Chathamborough Research Group, Inc. | 1990-08-17 | 86 | 0 |
| K863034 | SHARPOINT STAINLESS STEEL SUTURE | Chathamborough Research Group, Inc. | 1986-09-30 | 50 | 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