The Medical Group, Inc.: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “The Medical Group, Inc.” (first 1986, latest 1991), across 11 product codes in 4 review panels. Median 510(k) review time under this name: 30 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 |
|---|---|---|---|
| EAX | Mirror, Mouth | 2 | 2 |
| EFQ | Gauze/Sponge, Internal | 2 | 2 |
| IOQ | Bed, Flotation Therapy, Powered | 2 | 2 |
| NAB | Gauze / Sponge,Nonresorbable For External Use | 2 | 2 |
| DYN | Mouthpiece, Saliva Ejector | 1 | 1 |
| EFN | Cotton, Roll | 1 | 1 |
| EHZ | Evacuator, Oral Cavity | 1 | 1 |
| FLK | Thermometer, Clinical Mercury | 1 | 1 |
| FNL | Bed, Ac-Powered Adjustable Hospital | 1 | 1 |
| INX | Bed, Air Fluidized | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent The Medical Group, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K911246 | THE MEDISCUS PEDCARE MANAGEMENT SYSTEM-MODEL 2 | INX | 1991-06-06 | 77 |
| K901295 | PULMONAIR 40 PATIENT MANAGEMENT SYSTEM | IOQ | 1990-03-30 | 10 |
| K881843 | PEDIATRIC HOSPITAL BED | IOQ | 1988-10-26 | 177 |
| K881844 | MAGNUM 800(TM) MANAGEMENT SYSTEM | FNL | 1988-07-14 | 73 |
| K870284 | TRIANGULAR BANDAGE | — | 1987-02-24 | 28 |
| K870283 | 3 X 3 SPONGES, NON-STERILE | NAB | 1987-02-24 | 28 |
| K870282 | 4 X 4 SPONGES, NON-STERILE | NAB | 1987-02-24 | 28 |
| K870285 | THERMOMETER SHEATHES, STERILE (GLASS) | FLK | 1987-02-12 | 16 |
| K863769 | EVACUATOR TIPS | EHZ | 1986-10-30 | 35 |
| K863767 | GLASS MOUTH MIRRORS, REUSABLE | EAX | 1986-10-30 | 35 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named The Medical Group, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under The Medical Group, Inc.?
FDA lists 16 510(k) clearances under the applicant name “The Medical Group, Inc.” (first 1986, latest 1991), across 11 product codes in 4 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 The Medical Group, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name The Medical Group, Inc. is 30 days.
Which FDA product codes appear under The Medical Group, Inc.?
The most frequent FDA product codes under this applicant name are EAX (Mirror, Mouth, 2); EFQ (Gauze/Sponge, Internal, 2); IOQ (Bed, Flotation Therapy, Powered, 2).
Next steps
- See all 16 The Medical Group, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EAX, The Medical Group, 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.