Citation Medical Corp.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Citation Medical Corp.” (first 1991, latest 1995), across 5 product codes in 4 review panels. Median 510(k) review time under this name: 90 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 |
|---|---|---|---|
| HRX | Arthroscope | 8 | 8 |
| EOB | Nasopharyngoscope (Flexible Or Rigid) | 1 | 1 |
| EOQ | Bronchoscope (Flexible Or Rigid) | 1 | 1 |
| FCG | Biopsy Needle | 1 | 1 |
| KKX | Drape, Surgical, Antimicrobial | 1 | 1 |
Review panels
Most recent Citation Medical Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K951941 | CITATION MULTIPLE USE DELTA SCOPE | HRX | 1995-07-14 | 80 |
| K945390 | CITATION DELTA SCOPE | HRX | 1995-06-23 | 232 |
| K946290 | CITATION POWER TOOL | HRX | 1995-06-15 | 170 |
| K951249 | CITATION SINUSCOPE | EOB | 1995-04-10 | 21 |
| K944976 | BRONCHOSCOPE,NON-RIGID | EOQ | 1994-12-21 | 71 |
| K940847 | ENDOSCOPIC PLANTAR FASCIA KIT | HRX | 1994-10-11 | 230 |
| K941563 | THE BIOPSY TOOL | FCG | 1994-09-26 | 178 |
| K924494 | CITSCOPE, BENDABLE -- MODIFICATION | HRX | 1993-05-26 | 272 |
| K922144 | CITSCOPE (MODEL EXTENSIONS) | HRX | 1992-08-05 | 91 |
| K921692 | INTEGRATED VIDEO SYSTEM | HRX | 1992-07-01 | 84 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Citation Medical 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 Citation Medical Corp.?
FDA lists 12 510(k) clearances under the applicant name “Citation Medical Corp.” (first 1991, latest 1995), across 5 product codes in 4 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 Citation Medical Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Citation Medical Corp. is 90 days.
Which FDA product codes appear under Citation Medical Corp.?
The most frequent FDA product codes under this applicant name are HRX (Arthroscope, 8); EOB (Nasopharyngoscope (Flexible Or Rigid), 1); EOQ (Bronchoscope (Flexible Or Rigid), 1).
Next steps
- See all 12 Citation Medical Corp. clearances with predicates and recalls
- Run predicate analysis for product code HRX, Citation Medical 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.