Midwest Rf, LLC: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Midwest Rf, LLC” (first 2000, latest 2011), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 62 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 |
|---|---|---|---|
| MOS | Coil, Magnetic Resonance, Specialty | 8 | 8 |
| OAP | Laser, Comb, Hair | 1 | 1 |
Review panels
Most recent Midwest Rf, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K111259 | SV DBS VRAIN ARRAY | MOS | 2011-07-05 | 62 |
| K091496 | MEP-90 HAIR GROWTH STIMULATION SYSTEM | OAP | 2010-02-23 | 279 |
| K090267 | SV DBS BRAIN ARRAY, MODEL 1500SV-SMS64 | MOS | 2009-03-16 | 41 |
| K051618 | SPECIAL PROCEDURES II HEAD COIL, MODEL 1400GE-64 | MOS | 2005-08-02 | 46 |
| K030317 | MODEL 1300GE-64: PEDIATRIC POSITIONER | MOS | 2003-03-25 | 54 |
| K003386 | SPECIAL PROCEDURES HEAD COIL; MODEL # 1100GE-64 | MOS | 2000-12-28 | 58 |
| K003097 | BRAIN COIL, MODEL 9800GE-64 | MOS | 2000-12-28 | 86 |
| K002860 | MODEL 6900GE-64: C-SPINE ARRAY | MOS | 2000-11-22 | 70 |
| K002864 | MODEL 6600GE-64: TRAMA NECK ARRAY | MOS | 2000-11-21 | 69 |
Recalls
openFDA lists no recalls under a recalling firm named Midwest Rf, LLC.
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 Midwest Rf, LLC (a text match, not an official crosswalk):
- C8900 — Magnetic resonance angiography with contrast, abdomen (via MOS)
- C8901 — Magnetic resonance angiography without contrast, abdomen (via MOS)
- C8918 — Magnetic resonance angiography with contrast, pelvis (via MOS)
- C8919 — Magnetic resonance angiography without contrast, pelvis (via MOS)
- C8902 — Magnetic resonance angiography without contrast followed by 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.
- Midwest (13 510(k)s)
- Midwest City Hearing Aid Center (12 510(k)s)
- Midwest Orthodontic Mfg. (7 510(k)s)
- Midwest Dental Products Corp. (5 510(k)s)
- Midwest Metabolic Support Group (4 510(k)s)
- Midwest Reprocessing Center, LLC (4 510(k)s)
- Midwest Analog & Digital, Inc. (3 510(k)s)
- Midwest Implant Sales, Inc. (3 510(k)s)
- Midwest X-Ray Equipment Co. (3 510(k)s)
- Midwest Eye Laboratories, Inc. (2 510(k)s)
- Midwest Development (1 510(k)s)
- Midwest Marketing Service (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Midwest Rf, LLC?
FDA lists 9 510(k) clearances under the applicant name “Midwest Rf, LLC” (first 2000, latest 2011), across 2 product codes in 2 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 Midwest Rf, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Midwest Rf, LLC is 62 days.
Which FDA product codes appear under Midwest Rf, LLC?
The most frequent FDA product codes under this applicant name are MOS (Coil, Magnetic Resonance, Specialty, 8); OAP (Laser, Comb, Hair, 1).
Next steps
- See all 9 Midwest Rf, LLC clearances with predicates and recalls
- Run predicate analysis for product code MOS, Midwest Rf, LLC'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.