Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Crystal Medical Products, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
102 daysmedian FDA review time
119 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K861513 | LA DIFFUSION TECHNIQUE, KTY CM-10 BREAST PUMP | Crystal Medical Products, Inc. | 1986-08-08 | 107 | 0 |
| K853107 | AXICARE CM-14 AUTOMATIC BREAST PUMP | Crystal Medical Products, Inc. | 1985-11-19 | 119 | 0 |
| K850753 | NATURAL MOTHER BREAST PUMP | Crystal Medical Products, Inc. | 1985-06-07 | 102 | 0 |
| K850242 | CRYSTAL MANUAL BREAST PUMP | Crystal Medical Products, Inc. | 1985-02-25 | 34 | 0 |
| K842766 | CRYSTAL MEDICAL MILK COLLECTION KIT | Crystal Medical Products, Inc. | 1984-09-25 | 71 | 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