Advantage Medical Systems, Inc.: FDA filings under this applicant name
FDA lists 17 510(k) clearances under the applicant name “Advantage Medical Systems, Inc.” (first 1980, latest 1987), across 8 product codes in 5 review panels. Median 510(k) review time under this name: 48 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 |
|---|---|---|---|
| HGM | System, Monitoring, Perinatal | 9 | 9 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 2 | 2 |
| FMI | Needle, Hypodermic, Single Lumen | 1 | 1 |
| HFM | Monitor, Uterine Contraction, External (For Use In Clinic) | 1 | 1 |
| IWE | Monitor, Patient Position, Light-Beam | 1 | 1 |
| LLZ | System, Image Processing, Radiological | 1 | 1 |
| LRP | Tray, Surgical | 1 | 1 |
Plus 1 more product codes.
Review panels
- Obstetrics and Gynecology (10)
- Cardiovascular (2)
- Radiology (2)
- General Hospital (1)
- General and Plastic Surgery (1)
Most recent Advantage Medical Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K873957 | NON-CORING HUBER TYPE NEEDLES | FMI | 1987-10-23 | 25 |
| K873290 | LACERATION AND INSTRUMENT TRAYS | LRP | 1987-09-24 | 38 |
| K863494 | NEONATAL PHYSIOLOGICAL MONITOR MODEL PM 20 | DRT | 1986-12-22 | 104 |
| K861556 | MODIFIED FETAL MONITOR MODEL FM-2 | HGM | 1986-07-07 | 73 |
| K861279 | FLUORO PLUS | LLZ | 1986-06-16 | 70 |
| K861455 | MODEL DT-102 DATA TELEPHONE TRANSMITTER | HGM | 1986-05-30 | 42 |
| K852518 | MODIFICATION FETAL MONITOR MODEL FM-2 | HGM | 1985-07-05 | 23 |
| K844724 | FETAL TELEMETRY SYSTEM | HGM | 1985-05-01 | 148 |
| K842462 | HOLTER SCREENING MONITOR HS-221 | DRT | 1984-09-11 | 81 |
| K840747 | TOCO DATA TELEPHONE TRANSMITTER DT100P | HFM | 1984-06-19 | 117 |
7 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Advantage Medical Systems, 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.
- Advantage Diagnostics Corp. (10 510(k)s)
- Advantage Credit Services, Inc. (4 510(k)s)
- Advantage Dental Products, Inc. (3 510(k)s)
- Advantage Medical Division of Cme Telemetrix (2 510(k)s)
- Advantage Dental Co. (1 510(k)s)
- Advantage Medical Cables, Inc. (1 510(k)s)
- Advantage Medical Device (1 510(k)s)
- Advantage Medical Electronics, Inc. (1 510(k)s)
- Advantage Medical Services, Inc. (1 510(k)s)
- Advantage Resources (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Advantage Medical Systems, Inc.?
FDA lists 17 510(k) clearances under the applicant name “Advantage Medical Systems, Inc.” (first 1980, latest 1987), across 8 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 Advantage Medical Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Advantage Medical Systems, Inc. is 48 days.
Which FDA product codes appear under Advantage Medical Systems, Inc.?
The most frequent FDA product codes under this applicant name are HGM (System, Monitoring, Perinatal, 9); DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), 2); FMI (Needle, Hypodermic, Single Lumen, 1).
Next steps
- See all 17 Advantage Medical Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HGM, Advantage Medical Systems, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.