Vitalcare Group, Inc.: FDA clearances and approvals
Vitalcare Group, Inc. has 8 FDA 510(k) clearances (first 1998, latest 2006), across 7 product codes in 4 review panels. Median 510(k) review time: 119 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LYZ | Vinyl Patient Examination Glove | 2 | 2 |
| EFQ | Gauze/Sponge, Internal | 1 | 1 |
| EZL | Catheter, Retention Type, Balloon | 1 | 1 |
| FPA | Set, Administration, Intravascular | 1 | 1 |
| HIB | Speculum, Vaginal, Nonmetal | 1 | 1 |
| LYY | Latex Patient Examination Glove | 1 | 1 |
| MEG | Syringe, Antistick | 1 | 1 |
Review panels
- General Hospital (5)
- Gastroenterology and Urology (1)
- Obstetrics and Gynecology (1)
- General and Plastic Surgery (1)
Most recent Vitalcare Group, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K060109 | OMI RETRACTABLE SAFETY SYRINGE | MEG | 2006-05-05 | 112 |
| K050906 | VITALCARE I.V. ADMINISTRATION SET | FPA | 2005-08-23 | 134 |
| K040916 | VITALCARE POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVE | LYZ | 2005-05-04 | 391 |
| K031748 | VITALCARE STERILEWATER AND 0.9% SODIUM CHLORIDE PRE-FILLED 10CC/30CC SYRINGES | EZL | 2003-08-27 | 83 |
| K992289 | VINYL POWDERED EXAM GLOVE / CAT.# 15-020 | LYZ | 1999-08-04 | 28 |
| K983016 | GAUZE, SPONGES, CAT # 11-003 | EFQ | 1999-02-12 | 168 |
| K983716 | VITALCARE DISPOSABLE VAGINAL SPECULUM | HIB | 1998-12-23 | 63 |
| K982901 | LATEX PATIENT EXAMINATION GLOVE, CAT. NO. 1000M POWDERED | LYY | 1998-12-21 | 126 |
Recalls
openFDA lists no recalls under a recalling firm named Vitalcare Group, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Vitalcare Group, Inc. have?
Vitalcare Group, Inc. has 8 FDA 510(k) clearances (first 1998, latest 2006), across 7 product codes in 4 review panels.
How long does FDA take to clear Vitalcare Group, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Vitalcare Group, Inc.'s cleared 510(k)s is 119 days.
What devices does Vitalcare Group, Inc. make?
Its most frequent FDA product codes are LYZ (Vinyl Patient Examination Glove, 2); EFQ (Gauze/Sponge, Internal, 1); EZL (Catheter, Retention Type, Balloon, 1).
Has Vitalcare Group, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Vitalcare Group, Inc. Related entities may recall under other names.
Next steps
- See all 8 Vitalcare Group, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LYZ, Vitalcare Group, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.