Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Infection Control 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) |
|---|---|---|---|---|---|
| K935779 | AGAFAR FACE SHIELD | Infection Control Products, Inc. | 1994-02-01 | 60 | 0 |
| K900643 | FLUID SOAKERSHIELD | Infection Control Products, Inc. | 1990-04-25 | 75 | 0 |
| K900644 | I.V. FREEDOM CLIP | Infection Control Products, Inc. | 1990-03-09 | 28 | 0 |
| K900175 | 4/1 ARMBOARD | Infection Control Products, Inc. | 1990-01-24 | 12 | 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