Advanced Medical Systems, Inc.: FDA clearances and approvals
Advanced Medical Systems, Inc. has 10 FDA 510(k) clearances (first 1988, latest 1996), across 8 product codes in 3 review panels. Median 510(k) review time: 194 days.
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 |
|---|---|---|---|
| HGL | Transducer, Ultrasonic, Obstetric | 2 | 2 |
| HGM | System, Monitoring, Perinatal | 2 | 2 |
| BTY | Calculator, Predicted Values, Pulmonary Function | 1 | 1 |
| BZG | Spirometer, Diagnostic | 1 | 1 |
| DQA | Oximeter | 1 | 1 |
| HEK | Monitor, Heart Sound, Fetal, Ultrasonic | 1 | 1 |
| HGP | Electrode, Circular (Spiral), Scalp And Applicator | 1 | 1 |
| KPQ | System, Simulation, Radiation Therapy | 1 | 1 |
Review panels
- Obstetrics and Gynecology (6)
- Anesthesiology (3)
- Radiology (1)
Most recent Advanced Medical Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K955931 | MODEL IM77 INTRAPARTUM FETAL MONITOR (MODIFICATION) | HGM | 1996-08-14 | 243 |
| K952031 | ULTRASOUND TRANSDUCER, MODEL US917 | HGL | 1995-07-18 | 78 |
| K940898 | MODEL IM77 INTRAPARTUM FETAL MONITOR | HGM | 1995-03-01 | 370 |
| K923335 | ULTRASOUND TRANSUCER, MODEL US915 -- MODIFICATION | HGL | 1994-07-22 | 774 |
| K932278 | PFM PROFESSIONAL 7000 SPIROMETER | BTY | 1993-12-17 | 219 |
| K911657 | FETAL SCALP SPIRAL ELECTRODE | HGP | 1991-07-11 | 90 |
| K902190 | FETAL PULSE DETECTOR MODEL DOP-1 | HEK | 1990-10-22 | 159 |
| K894568 | NEW RAD-8 TREATMENT PLANNING COMPUTER SYSTEM | KPQ | 1990-01-09 | 172 |
| K891672 | PUL-TRON 100K PROFESSIONAL SPIROMETER | BZG | 1989-06-16 | 87 |
| K880756 | MODEL PM-20A PHYSIOLOGICAL MONITOR | DQA | 1988-09-27 | 215 |
Recalls
openFDA lists no recalls under a recalling firm named Advanced Medical Systems, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Advanced Medical Systems, Inc. have?
Advanced Medical Systems, Inc. has 10 FDA 510(k) clearances (first 1988, latest 1996), across 8 product codes in 3 review panels.
How long does FDA take to clear Advanced Medical Systems, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Advanced Medical Systems, Inc.'s cleared 510(k)s is 194 days.
What devices does Advanced Medical Systems, Inc. make?
Its most frequent FDA product codes are HGL (Transducer, Ultrasonic, Obstetric, 2); HGM (System, Monitoring, Perinatal, 2); BTY (Calculator, Predicted Values, Pulmonary Function, 1).
Has Advanced Medical Systems, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Advanced Medical Systems, Inc. Related entities may recall under other names.
Next steps
- See all 10 Advanced Medical Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HGL, Advanced Medical Systems, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.