Advance Medical Device, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Advance Medical Device, Inc.” (first 1990, latest 1997), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 81 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 |
|---|---|---|---|
| DPT | Probe, Blood-Flow, Extravascular | 1 | 1 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 1 | 1 |
| HIB | Speculum, Vaginal, Nonmetal | 1 | 1 |
| JAF | Monitor, Ultrasonic, Nonfetal | 1 | 1 |
| JOP | Transducer, Ultrasonic | 1 | 1 |
Review panels
- Cardiovascular (3)
- Obstetrics and Gynecology (1)
- Radiology (1)
Most recent Advance Medical Device, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K964697 | AMD HOME HEALTH MONITOR SYSTEM AND AMD MONITORING STATION | DXN | 1997-02-11 | 81 |
| K943200 | FLOSCOPE SUPER VASCULAR LAB | JAF | 1995-11-21 | 504 |
| K910441 | FLOSCOPE MICRODOP | DPT | 1991-03-21 | 49 |
| K905157 | FLOSCOPE VASCULAR LAB. | JOP | 1991-03-15 | 119 |
| K903744 | PHYSICIAN'S CHOICE | HIB | 1990-09-12 | 27 |
Recalls
openFDA lists no recalls under a recalling firm named Advance Medical Device, 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.
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.
- Advance Medical Designs, Inc. (32 510(k)s)
- Advance Suture, Inc. (5 510(k)s)
- Advance Rubber, Inc. (3 510(k)s)
- Advance Corp. (1 510(k)s)
- Advance Tech Intl. (1 510(k)s)
- Advance Sentry Corporation (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Advance Medical Device, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Advance Medical Device, Inc.” (first 1990, latest 1997), across 5 product codes in 3 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 Advance Medical Device, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Advance Medical Device, Inc. is 81 days.
Which FDA product codes appear under Advance Medical Device, Inc.?
The most frequent FDA product codes under this applicant name are DPT (Probe, Blood-Flow, Extravascular, 1); DXN (System, Measurement, Blood-Pressure, Non-Invasive, 1); HIB (Speculum, Vaginal, Nonmetal, 1).
Next steps
- See all 5 Advance Medical Device, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DPT, Advance Medical Device, 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.