Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Steri-Shield Products, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
162 daysmedian FDA review time
162 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K884221 | ULTRASONIC SCALER COVER | Steri-Shield Products, Inc. | 1989-03-17 | 162 | 0 |
| K884220 | AIR WATER SYRINGE TIP SHIELD | Steri-Shield Products, Inc. | 1989-03-17 | 162 | 0 |
| K884222 | CURING LIGHT COVER | Steri-Shield Products, Inc. | 1989-03-17 | 162 | 0 |
| K884223 | DENTAL LAMP HANDLE COVER | Steri-Shield Products, Inc. | 1989-03-17 | 162 | 0 |
| K884219 | BRACKET TABLE ARM COVER | Steri-Shield Products, Inc. | 1989-03-17 | 162 | 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