Advanced Medical Products, Inc.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Advanced Medical Products, Inc.” (first 1985, latest 2000), across 10 product codes in 5 review panels. Median 510(k) review time under this name: 87 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 |
|---|---|---|---|
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 3 | 3 |
| DSH | Recorder, Magnetic Tape, Medical | 2 | 2 |
| DSI | Detector And Alarm, Arrhythmia | 2 | 2 |
| DSF | Recorder, Paper Chart | 1 | 1 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 1 | 1 |
| FAP | Cystometric Gas (Carbon-Dioxide) On Hydraulic Device | 1 | 1 |
| GAH | Stylet, Surgical, General & Plastic Surgery | 1 | 1 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 1 | 1 |
| JAF | Monitor, Ultrasonic, Nonfetal | 1 | 1 |
| LOS | 1 | 1 |
Review panels
- Cardiovascular (6)
- Neurology (3)
- Radiology (2)
- Gastroenterology and Urology (1)
- General and Plastic Surgery (1)
Most recent Advanced Medical Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K000932 | ARACHNOPHLEBECTOMY NEEDLE | GAH | 2000-05-17 | 55 |
| K923995 | URODYNAMICS TUBING KITS #5161, #5150, #7170 | FAP | 1993-04-08 | 241 |
| K921426 | ULTRA PCI | IYO | 1992-10-05 | 195 |
| K912925 | ULTRA PVD | JAF | 1992-06-18 | 351 |
| K915658 | SPECTRA ECG | LOS | 1992-06-10 | 175 |
| K896103 | MICRO FL 7400 AMBULATORY HOLTER/BP MONITOR | DSI | 1990-01-18 | 87 |
| K896102 | MICRO FD 7000 AMBULATORY BLOOD PRESSURE MONITOR | DXN | 1990-01-18 | 87 |
| K881905 | MODEL MICRO SI AMBULATORY ECG MONITOR | DSI | 1988-08-02 | 88 |
| K872508 | MODEL MICRO FD+ AMBULATORY ECG MONITOR | DSH | 1987-09-25 | 93 |
| K870538 | MODEL 192 PRINTER | DSF | 1987-04-23 | 73 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Advanced Medical Products, 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.
- Advanced Cardiovascular Systems, Inc. (103 510(k)s)
- Advanced Surgical Products, Inc. (64 510(k)s)
- Advanced Technology Laboratories, Inc. (61 510(k)s)
- Advanced Sterilization Products (59 510(k)s)
- Advanced Neuromodulation Systems (25 510(k)s)
- Advanced Orthopaedic Solutions, Inc. (24 510(k)s)
- Advanced Biosearch Assn. (22 510(k)s)
- Advanced Biomedical Methods, Inc. (21 510(k)s)
- Advanced Surgical, Inc. (21 510(k)s)
- Advanced Clinical Diagnostics (19 510(k)s)
- Advanced Instrumentations, Inc. (16 510(k)s)
- Advanced Instruments, Inc. (16 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Advanced Medical Products, Inc.?
FDA lists 14 510(k) clearances under the applicant name “Advanced Medical Products, Inc.” (first 1985, latest 2000), across 10 product codes in 5 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 Advanced Medical Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Advanced Medical Products, Inc. is 87 days.
Which FDA product codes appear under Advanced Medical Products, Inc.?
The most frequent FDA product codes under this applicant name are GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief, 3); DSH (Recorder, Magnetic Tape, Medical, 2); DSI (Detector And Alarm, Arrhythmia, 2).
Next steps
- See all 14 Advanced Medical Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GZJ, Advanced Medical Products, 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.