Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sterile Design, Inc. · Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
154 daysmedian FDA review time
543 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K934688 | STERILE DESIGN | Sterile Design, Inc. | 1994-03-16 | 167 | 0 |
| K841960 | CARDIO METRICS INVASIVE PRESSURE MONIT | Sterile Design, Inc. | 1985-11-08 | 543 | 0 |
| K842356 | CUSTOM STERILE PROCEDURE KITS | Sterile Design, Inc. | 1985-03-21 | 279 | 0 |
| K841959 | CARDIO METRIC CUSTOM PERFUSION TUBING | Sterile Design, Inc. | 1984-10-19 | 158 | 1 |
| K841958 | CARDIO METRICS CARDIOTOMY RESERVOIR | Sterile Design, Inc. | 1984-10-15 | 154 | 0 |
| K842351 | STERILE DESIGN-CUSTOM STERILE IV KIT | Sterile Design, Inc. | 1984-10-15 | 122 | 0 |
| K834239 | SDI C-FLEX STERILE LIGHT HANDLE | Sterile Design, Inc. | 1984-04-25 | 141 | 0 |
| K834237 | GRADUATED GUIDE WIRE BOWL 8 | Sterile Design, Inc. | 1984-02-04 | 60 | 0 |
| K813437 | PAN SET | Sterile Design, Inc. | 1981-12-31 | 23 | 0 |
| K791738 | CUSTOM DRESSING CHANGE TRAYS | Sterile Design, Inc. | 1979-10-02 | 33 | 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