Dravon Medical, Inc.: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “Dravon Medical, Inc.” (first 1977, latest 1987), across 13 product codes in 6 review panels. Median 510(k) review time under this name: 59 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 |
|---|---|---|---|
| KDJ | Set, Administration, For Peritoneal Dialysis, Disposable | 3 | 3 |
| FJS | Catheter, Peritoneal, Long-Term Indwelling | 2 | 2 |
| DQR | Cannula, Catheter | 1 | 1 |
| FJK | Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | 1 | 1 |
| FJZ | Declotting Tray, Kit (Including Contents) | 1 | 1 |
| GEN | Forceps, General & Plastic Surgery | 1 | 1 |
| HQC | Unit, Phacofragmentation | 1 | 1 |
| HTD | Forceps | 1 | 1 |
| KDC | Instrument, Surgical, Disposable | 1 | 1 |
| KNR | Adapter, A-V Shunt Or Fistula | 1 | 1 |
Plus 3 more product codes.
Review panels
- Gastroenterology and Urology (9)
- General and Plastic Surgery (3)
- Cardiovascular (1)
- Hematology (1)
- General Hospital (1)
- Ophthalmic (1)
Most recent Dravon Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K873455 | S3086 ARTERIAL, S3087 VENOUS NEONATAL HEMODIALYSIS | FJK | 1987-09-14 | 17 |
| K860770 | AM-100 I/A AMPAC | HQC | 1986-04-21 | 49 |
| K832739 | STEDIFLO INFUSION SET | LDR | 1983-12-22 | 129 |
| K831842 | DRAVON T CLAMP | KDC | 1983-09-26 | 110 |
| K812772 | PERITONEAL DIALYSIS CYCLER SET (8UNIT) | KDJ | 1981-10-19 | 14 |
| K812771 | PERITONEAL DIALYSIS DRAINAGE | KDJ | 1981-10-19 | 14 |
| K811851 | S-610 SHUNT ADAPTOR SET | KNR | 1981-08-31 | 61 |
| K800435 | HEMOSTATIC/TUBE OCCLUDING FORCEPS | GEN | 1980-03-12 | 14 |
| K782058 | CATHETER, BETA-CAP-PERITONEAL | FJS | 1979-02-27 | 82 |
| K782057 | CATHETER, RADIOPAQUE TENCKHOFF | FJS | 1979-02-27 | 82 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Dravon Medical, 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 Dravon Medical, Inc.?
FDA lists 16 510(k) clearances under the applicant name “Dravon Medical, Inc.” (first 1977, latest 1987), across 13 product codes in 6 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 Dravon Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Dravon Medical, Inc. is 59 days.
Which FDA product codes appear under Dravon Medical, Inc.?
The most frequent FDA product codes under this applicant name are KDJ (Set, Administration, For Peritoneal Dialysis, Disposable, 3); FJS (Catheter, Peritoneal, Long-Term Indwelling, 2); DQR (Cannula, Catheter, 1).
Next steps
- See all 16 Dravon Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KDJ, Dravon Medical, 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, 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.