Graham Medical Products: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Graham Medical Products” (first 1986, latest 1993), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 189 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 |
|---|---|---|---|
| KKX | Drape, Surgical, Antimicrobial | 6 | 6 |
| EJJ | Alloy, Amalgam | 1 | 1 |
| FMG | Stopcock, I.V. Set | 1 | 1 |
| FRG | Wrap, Sterilization | 1 | 1 |
Review panels
- General Hospital (8)
- Dental (1)
Most recent Graham Medical Products 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K921657 | VASECTOMY DRAPE | KKX | 1993-03-18 | 345 |
| K922100 | DISPOSABLE TURP FLUID CONTAINMENT DRAPE - STERILE | EJJ | 1993-03-15 | 315 |
| K922059 | DISPOSABLE CYSTOSCOPY SPLASH DRAPE-STERILE #599 | KKX | 1993-03-03 | 309 |
| K913448 | DISPOSABLE TURP FLUID CONTAINMENT DRAPE - STERILE | KKX | 1992-02-07 | 189 |
| K913447 | DISPOSABLE CYSTOSCOPY SPLASH DRAPE-STERILE #599 | KKX | 1992-02-07 | 189 |
| K913560 | STOPCOCK | FMG | 1991-12-31 | 144 |
| K903726 | DRAPE, SURGICAL - UTILITY DRAPE - STERILE | KKX | 1990-08-27 | 11 |
| K863981 | STERILIZATION WRAPS #620,624,648,640,636,630,612 | FRG | 1986-11-25 | 42 |
| K864111 | STERILE FIELD #605 FENESTRATED STERILE FIELD #606 | KKX | 1986-10-30 | 9 |
Recalls
openFDA lists no recalls under a recalling firm named Graham Medical Products.
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.
- Graham Medical Technologies, LLC (2 510(k)s)
- Graham Medical Technologies, LLC Dba Gramedica (2 510(k)s)
- Graham & James (1 510(k)s)
- Graham Manufacturing Co. (1 510(k)s)
- Graham Medical Technologies, LLC (D.B.A.Gramedica) (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Graham Medical Products?
FDA lists 9 510(k) clearances under the applicant name “Graham Medical Products” (first 1986, 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 Graham Medical Products?
The median time from FDA receipt to decision across 510(k)s cleared under the name Graham Medical Products is 189 days.
Which FDA product codes appear under Graham Medical Products?
The most frequent FDA product codes under this applicant name are KKX (Drape, Surgical, Antimicrobial, 6); EJJ (Alloy, Amalgam, 1); FMG (Stopcock, I.V. Set, 1).
Next steps
- See all 9 Graham Medical Products clearances with predicates and recalls
- Run predicate analysis for product code KKX, Graham Medical Products'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.