Graham-Field, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Graham-Field, Inc.” (first 1989, latest 1997), across 7 product codes in 4 review panels. Median 510(k) review time under this name: 83 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 |
|---|---|---|---|
| DPS | Electrocardiograph | 2 | 2 |
| CAF | Nebulizer (Direct Patient Interface) | 1 | 1 |
| DQD | Stethoscope, Electronic | 1 | 1 |
| FRO | Dressing, Wound, Drug | 1 | 1 |
| GZT | Retractor, Self-Retaining, For Neurosurgery | 1 | 1 |
| KGX | Tape And Bandage, Adhesive | 1 | 1 |
| LOS | 1 | 1 |
Review panels
- Cardiovascular (3)
- General and Plastic Surgery (2)
- Anesthesiology (1)
- Neurology (1)
Most recent Graham-Field, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K970035 | JOHN BUNN NEB-U-LITE II MEDICATION COMPRESSOR WITH DISPOSABLE NEBULIZER, MODEL #JBO-112-009 | CAF | 1997-04-01 | 88 |
| K961857 | LABTRON ELECTROMAX ELECTRONIC STETHOSCOPE MODEL NO. 04-1060 | DQD | 1996-07-03 | 50 |
| K924876 | TENS DEVICE FOR RELIEF OF CHRONIC PAIN, MODIFIED | GZT | 1994-03-01 | 524 |
| K904904 | MEDICOPASTE BANDAGE WITH CALAMINE/MODIFICATION | KGX | 1991-03-19 | 140 |
| K901948 | CARDISUNY 501BIII | DPS | 1990-07-17 | 78 |
| K901947 | CARDISUNY 501AB | DPS | 1990-07-17 | 78 |
| K900849 | CARDISUNY, 501BX | LOS | 1990-04-04 | 41 |
| K883224 | UNNA BOOT DRESSING W/CALAMINE | FRO | 1989-01-05 | 160 |
Recalls
openFDA lists no recalls under a recalling firm named Graham-Field, 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Graham-Field, Inc. (a text match, not an official crosswalk):
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 Products (9 510(k)s)
- 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-Field, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Graham-Field, Inc.” (first 1989, latest 1997), across 7 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 Graham-Field, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Graham-Field, Inc. is 83 days.
Which FDA product codes appear under Graham-Field, Inc.?
The most frequent FDA product codes under this applicant name are DPS (Electrocardiograph, 2); CAF (Nebulizer (Direct Patient Interface), 1); DQD (Stethoscope, Electronic, 1).
Next steps
- See all 8 Graham-Field, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DPS, Graham-Field, 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.