Critical Device Corp.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Critical Device Corp.” (first 1996, latest 1999), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 93 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 |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | 4 | 4 |
| LHI | Set, I.V. Fluid Transfer | 2 | 2 |
Review panels
- General Hospital (6)
Most recent Critical Device Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K983926 | MPS GRAVITY FLOW CONTROL SET | FPA | 1999-01-20 | 76 |
| K964918 | NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER WITH POSIFLOW POSITIVE DISPLACEMENT FEATURE, AND I.V. SETS | FPA | 1997-04-14 | 126 |
| K964989 | CDC VIAL AND BAG ACCESS PIN (CDC-P-1/P-2/P-3/P-4/P-5) | LHI | 1997-04-02 | 110 |
| K964812 | NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER AND I.V. SET | FPA | 1997-02-10 | 73 |
| K952852 | NIMA (NEEDLELESS INJECTIONSITE MASTER ADAPTER) & I.V. SET | FPA | 1996-02-16 | 240 |
| K955896 | MACROBORE TUBING - CDC-F-1 THROUGH CDC-F-11 | LHI | 1996-02-06 | 39 |
Recalls
openFDA lists no recalls under a recalling firm named Critical Device 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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Critical Alert (1 510(k)s)
- Critical Care Diagnostics, Inc. (Dba Critical Diag (1 510(k)s)
- Critical Care Micro Computing (1 510(k)s)
- Critical Care Systems, Inc. (1 510(k)s)
- Critical Patient Care, Inc. (1 510(k)s)
- Critical Specialties, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Critical Device Corp.?
FDA lists 6 510(k) clearances under the applicant name “Critical Device Corp.” (first 1996, latest 1999), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Critical Device Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Critical Device Corp. is 93 days.
Which FDA product codes appear under Critical Device Corp.?
The most frequent FDA product codes under this applicant name are FPA (Set, Administration, Intravascular, 4); LHI (Set, I.V. Fluid Transfer, 2).
Next steps
- See all 6 Critical Device Corp. clearances with predicates and recalls
- Run predicate analysis for product code FPA, Critical Device 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.