Advanced Medical Technology, Inc.: FDA clearances and approvals
Advanced Medical Technology, Inc. has 8 FDA 510(k) clearances (first 1985, latest 2009), across 7 product codes in 5 review panels. Median 510(k) review time: 52 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 |
|---|---|---|---|
| HQC | Unit, Phacofragmentation | 2 | 2 |
| DSH | Recorder, Magnetic Tape, Medical | 1 | 1 |
| IDC | Acridine Orange | 1 | 1 |
| JOM | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic | 1 | 1 |
| JWX | Kit, Screening, Staphylococcus Aureus | 1 | 1 |
| KJK | Auramine O | 1 | 1 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 1 | 1 |
Review panels
- Cardiovascular (2)
- Ophthalmic (2)
- Pathology (2)
- Microbiology (1)
- Orthopedic (1)
Most recent Advanced Medical Technology, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K083626 | DISTRACTABLE WAVE CAGE | MAX | 2009-10-19 | 315 |
| K983900 | VENOMETER | JOM | 1999-01-29 | 87 |
| K874571 | PATIENTWATCH (TM) | DSH | 1988-01-29 | 85 |
| K862777 | MODEL A-8000 ULTRASONIC HANDPIECE CORD | HQC | 1986-08-11 | 20 |
| K854225 | ALLERGAN I.S.P. MODEL 3000 OPHTHALMIC SURGICAL-SYS | HQC | 1985-12-27 | 70 |
| K852997 | RAPI - STAPH | JWX | 1985-08-19 | 35 |
| K853187 | ACRIDINE ORANGE FLUORESCENT STAIN | IDC | 1985-08-13 | 14 |
| K853081 | AURAMINE O FLUORESCENT MYCOBACTERIAL STAIN SET | KJK | 1985-08-13 | 21 |
Recalls
openFDA lists no recalls under a recalling firm named Advanced Medical Technology, 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 Technology, Inc. have?
Advanced Medical Technology, Inc. has 8 FDA 510(k) clearances (first 1985, latest 2009), across 7 product codes in 5 review panels.
How long does FDA take to clear Advanced Medical Technology, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Advanced Medical Technology, Inc.'s cleared 510(k)s is 52 days.
What devices does Advanced Medical Technology, Inc. make?
Its most frequent FDA product codes are HQC (Unit, Phacofragmentation, 2); DSH (Recorder, Magnetic Tape, Medical, 1); IDC (Acridine Orange, 1).
Has Advanced Medical Technology, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Advanced Medical Technology, Inc. Related entities may recall under other names.
Next steps
- See all 8 Advanced Medical Technology, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HQC, Advanced Medical Technology, 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.