Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Life-Shield Products, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
63 daysmedian FDA review time
113 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K072037 | CAREO SAFETY SYRINGE FOR U-100 INSULIN 0.5CC/ML | Life-Shield Products, Inc. | 2007-08-08 | 14 | 0 |
| K061055 | CAREO SAFETY SYRINGE FOR U-100 INSULIN | Life-Shield Products, Inc. | 2006-07-10 | 84 | 0 |
| K060208 | CAREO SAFETY SYRINGE 1CC/ML, MODELS CA0106-C,CA0196-C,CA0186 | Life-Shield Products, Inc. | 2006-03-10 | 42 | 0 |
| K052397 | CAREO SAFETY SYRINGE (3CC/ML, 5CC/ML, 10CC/ML) | Life-Shield Products, Inc. | 2005-12-22 | 113 | 0 |
| K030976 | CAREO RETRACTABLE SAFETY SYRINGE | Life-Shield Products, Inc. | 2003-05-30 | 63 | 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