Kvm Technologies, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Kvm Technologies, Inc.” (first 1988, latest 1993), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 22 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 |
|---|---|---|---|
| GIF | Diluent, Blood Cell | 2 | 2 |
| BXB | Exerciser, Powered | 1 | 1 |
| GGK | Products, Red-Cell Lysing Products | 1 | 1 |
| GKK | Cyanomethemoglobin | 1 | 1 |
Review panels
- Hematology (4)
- Physical Medicine (1)
Most recent Kvm Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K925666 | THERAPACER 3000 | BXB | 1993-03-09 | 119 |
| K883992 | KVM PREPACK HEMATOLOGY REAGENT SET | GKK | 1988-10-12 | 22 |
| K883991 | KVM HEMOGLOBIN LYSING REAGENT | GGK | 1988-10-12 | 22 |
| K883990 | KVM ISOTONIC DILUENT | GIF | 1988-10-12 | 22 |
| K883989 | KVM ISOTONIC FLUSH SOLUTION | GIF | 1988-10-12 | 22 |
Recalls
openFDA lists no recalls under a recalling firm named Kvm Technologies, Inc..
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 Kvm Technologies, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Kvm Technologies, Inc.” (first 1988, latest 1993), across 4 product codes in 2 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 Kvm Technologies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Kvm Technologies, Inc. is 22 days.
Which FDA product codes appear under Kvm Technologies, Inc.?
The most frequent FDA product codes under this applicant name are GIF (Diluent, Blood Cell, 2); BXB (Exerciser, Powered, 1); GGK (Products, Red-Cell Lysing Products, 1).
Next steps
- See all 5 Kvm Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GIF, Kvm Technologies, Inc.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.