Vitaphore Corp.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Vitaphore Corp.” (first 1986, latest 1992), across 8 product codes in 5 review panels. Median 510(k) review time under this name: 91 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 2 | 2 |
| KGX | Tape And Bandage, Adhesive | 2 | 2 |
| KMK | Device, Intravascular Catheter Securement | 2 | 2 |
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 2 | 2 |
| MOE | Collagen Corneal Shield | 2 | 2 |
| FRO | Dressing, Wound, Drug | 1 | 1 |
| HBA | Neurosurgical Paddie | 1 | 1 |
| JEC | Component, Traction, Invasive | 1 | 1 |
Review panels
- General Hospital (6)
- General and Plastic Surgery (3)
- Ophthalmic (2)
- Neurology (1)
- Orthopedic (1)
Most recent Vitaphore Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K914579 | SILVER FOAM WOUND DRESSING | FRO | 1992-02-21 | 128 |
| K913148 | COLLAGEN SHIELD FOR ACUTE CARE | MOE | 1991-10-15 | 91 |
| K895920 | VITAPATCH PIN PROTECTION DEVICE FOR PERCUTANEOUS | KGX | 1991-06-06 | 603 |
| K902558 | COLLAGEN SHIELD FOR ACUTE CARE | MOE | 1990-08-17 | 67 |
| K891993 | COLLAGEN NEUROSPONGE | HBA | 1990-03-23 | 360 |
| K896455 | VITACHOICE WOUND DRESSING | KGX | 1990-02-15 | 98 |
| K896046 | VITAPATCH CATH. SECUREMENT DEVICE W/CHLORHEXIDINE | KMK | 1990-01-11 | 86 |
| K895993 | VITAPATCH ANTIMICROBIAL CATHETER SECUREMENT DEVICE | KMK | 1990-01-11 | 90 |
| K890435 | VITAACCESS CATHETER INTRODUCER KIT | FOZ | 1989-03-29 | 61 |
| K882100 | VITACUFF(R) PERCUTANEOUS INFECT. CONTROL KIT | LJS | 1988-07-13 | 55 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Vitaphore Corp..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Vitaphore Corp.?
FDA lists 13 510(k) clearances under the applicant name “Vitaphore Corp.” (first 1986, latest 1992), across 8 product codes in 5 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Vitaphore Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Vitaphore Corp. is 91 days.
Which FDA product codes appear under Vitaphore Corp.?
The most frequent FDA product codes under this applicant name are FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, 2); KGX (Tape And Bandage, Adhesive, 2); KMK (Device, Intravascular Catheter Securement, 2).
Next steps
- See all 13 Vitaphore Corp. clearances with predicates and recalls
- Run predicate analysis for product code FOZ, Vitaphore Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.