Medical Advances, Inc.: FDA filings under this applicant name
FDA lists 57 510(k) clearances under the applicant name “Medical Advances, Inc.” (first 1989, latest 2002), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 69 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 |
|---|---|---|---|
| LNH | System, Nuclear Magnetic Resonance Imaging | 38 | 38 |
| MOS | Coil, Magnetic Resonance, Specialty | 19 | 19 |
Review panels
- Radiology (57)
Most recent Medical Advances, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K023084 | MODEL 472GE-128: QUADRATURE LOWER EXTREMITY COIL | MOS | 2002-12-16 | 90 |
| K021433 | MODEL 415PH-64/42: PHASED ARRAY SHOULDER COIL | MOS | 2002-06-13 | 38 |
| K011608 | MODEL 235GE-64; MULTI PURPOSE FLEX ARRAY COIL | MOS | 2001-08-14 | 81 |
| K010074 | MODEL 455GE PHASED ARRAY WRIST COIL | MOS | 2001-04-03 | 84 |
| K003685 | MODEL 342GE-64 HIGH RESOLUTION BRAIN COIL | MOS | 2000-12-22 | 22 |
| K003144 | MODEL 205GE-64: PATHWAY MRI CAROTID ARRAY COIL | MOS | 2000-12-13 | 64 |
| K000345 | MULTI PURPOSE FLEX ARRAY COIL : MODEL 235 SERIES | MOS | 2000-04-11 | 68 |
| K991724 | QUADRATURE LOWER EXTREMITY COIL, MODEL 473PH-64 | MOS | 1999-08-02 | 74 |
| K991434 | QUADRATURE WRIST COIL, MODEL 445PH-64 | MOS | 1999-07-06 | 71 |
| K991113 | `INEAR WRIST COIL, MODEL 440GE-09 | MOS | 1999-06-10 | 70 |
47 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Medical Advances, 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Medical Advances, Inc. (a text match, not an official crosswalk):
- C8903 — Magnetic resonance imaging with contrast, breast; unilateral (via LNH)
- C8906 — Magnetic resonance imaging with contrast, breast; bilateral (via LNH)
- C8905 — Magnetic resonance imaging without contrast followed by with contrast, breast; unilateral (via LNH)
- C8908 — Magnetic resonance imaging without contrast followed by with contrast, breast; bilateral (via LNH)
- C8900 — Magnetic resonance angiography with contrast, abdomen (via MOS)
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.
- Medical Analysis Systems, Inc. (107 510(k)s)
- Medical Components, Inc. (63 510(k)s)
- Medical Diagnostic Technologies, Inc. (57 510(k)s)
- Medical Devices, Inc. (49 510(k)s)
- Medical Device Technologies, Inc. (46 510(k)s)
- Medical Specialties, Inc. (40 510(k)s)
- Medical Device Inspection Co., Inc. (30 510(k)s)
- Medical Engineering Corp. (28 510(k)s)
- Medical Data Electronics (27 510(k)s)
- Medical Graphics Corp. (25 510(k)s)
- Medical Innovations Corp. (24 510(k)s)
- Medical Instrument Development Laboratories, Inc. (23 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medical Advances, Inc.?
FDA lists 57 510(k) clearances under the applicant name “Medical Advances, Inc.” (first 1989, latest 2002), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Medical Advances, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medical Advances, Inc. is 69 days.
Which FDA product codes appear under Medical Advances, Inc.?
The most frequent FDA product codes under this applicant name are LNH (System, Nuclear Magnetic Resonance Imaging, 38); MOS (Coil, Magnetic Resonance, Specialty, 19).
Next steps
- See all 57 Medical Advances, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LNH, Medical Advances, 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.