Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Custom Surgical Products, 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) |
|---|---|---|---|---|---|
| K870874 | CSPI SPECIMEN TRAP (NON-STERILE) | Custom Surgical Products, Inc. | 1988-04-19 | 413 | 0 |
| K841249 | SUCTION CANNULAS | Custom Surgical Products, Inc. | 1984-06-04 | 75 | 0 |
| K841383 | CSPI ROTARY SURGICAL ASPIRATOR | Custom Surgical Products, Inc. | 1984-03-26 | 0 | 0 |
| K841242 | CSPI PREMIUM SURGICAL ASPIRATOR | Custom Surgical Products, Inc. | 1984-03-23 | 0 | 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