Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Vitalcare Group, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
126 daysmedian FDA review time
391 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K060109 | OMI RETRACTABLE SAFETY SYRINGE | Vitalcare Group, Inc. | 2006-05-05 | 112 | 0 |
| K050906 | VITALCARE I.V. ADMINISTRATION SET | Vitalcare Group, Inc. | 2005-08-23 | 134 | 0 |
| K040916 | VITALCARE POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVE | Vitalcare Group, Inc. | 2005-05-04 | 391 | 0 |
| K031748 | VITALCARE STERILEWATER AND 0.9% SODIUM CHLORIDE PRE-FILLED 1 | Vitalcare Group, Inc. | 2003-08-27 | 83 | 0 |
| K992289 | VINYL POWDERED EXAM GLOVE / CAT.# 15-020 | Vitalcare Group, Inc. | 1999-08-04 | 28 | 0 |
| K983016 | GAUZE, SPONGES, CAT # 11-003 | Vitalcare Group, Inc. | 1999-02-12 | 168 | 0 |
| K983716 | VITALCARE DISPOSABLE VAGINAL SPECULUM | Vitalcare Group, Inc. | 1998-12-23 | 63 | 0 |
| K982901 | LATEX PATIENT EXAMINATION GLOVE, CAT. NO. 1000M POWDERED | Vitalcare Group, Inc. | 1998-12-21 | 126 | 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