Doctor'S Research Group, Inc.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Doctor'S Research Group, Inc.” (first 1998, latest 2005), across 11 product codes in 6 review panels. Median 510(k) review time under this name: 188 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 |
|---|---|---|---|
| DQD | Stethoscope, Electronic | 2 | 2 |
| DZL | Screw, Fixation, Intraosseous | 2 | 2 |
| DYX | Lock, Wire, And Ligature, Intraoral | 1 | 1 |
| GXP | Methyl Methacrylate For Cranioplasty | 1 | 1 |
| HEI | Monitor, Heart-Valve Movement, Fetal, Ultrasonic | 1 | 1 |
| HHT | Spatula, Cervical, Cytological | 1 | 1 |
| HIB | Speculum, Vaginal, Nonmetal | 1 | 1 |
| HWC | Screw, Fixation, Bone | 1 | 1 |
| JEY | Plate, Bone | 1 | 1 |
| KHJ | Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material) | 1 | 1 |
Plus 1 more product codes.
Review panels
- Dental (4)
- Obstetrics and Gynecology (3)
- Cardiovascular (2)
- Orthopedic (2)
- Ear, Nose and Throat (1)
- Neurology (1)
Most recent Doctor'S Research Group, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K051487 | DRG LARYNGEAL AUGMENTATION IMPLANT DEVICE | KHJ | 2005-12-22 | 199 |
| K041018 | DRG SOFTRELEASE | HHT | 2004-10-18 | 181 |
| K012535 | DRG DISPOSABLE VAGINAL SPECULUM | HIB | 2002-03-01 | 206 |
| K012003 | DRG REACTION CHAMBER/SAFETY TIP | HEI | 2002-02-12 | 230 |
| K011736 | DRG QUICKMIX | GXP | 2002-01-30 | 239 |
| K013786 | DRG ORTHOHEX SS BONE SCREW | HWC | 2001-12-17 | 33 |
| K002047 | DRG PURETONE STETHOSCOPE WITH DRG ANTIMICROBIAL, STETHOSCOPE DIAPHRAGM, MODEL PT2B27(CARDIOLOGY), PT3B27(CLASSIC), PT5B2 | DQD | 2000-11-22 | 139 |
| K991714 | DRG CONVENTIONAL ELECTRONIC DIGITAL STETHOSCOPE, MODEL ECHOP 200-00 | DQD | 1999-12-10 | 204 |
| K990212 | LOCKJAW 15 MINUTE INTERMAXILLARY FIXATION SYSTEM,MODEL LJ100-00 | DYX | 1999-09-14 | 235 |
| K990920 | DRG TITANIUM BONE PLATE | JEY | 1999-06-10 | 84 |
3 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2012-04-06.
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 Doctor'S Research Group, Inc.?
FDA lists 13 510(k) clearances under the applicant name “Doctor'S Research Group, Inc.” (first 1998, latest 2005), across 11 product codes in 6 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 Doctor'S Research Group, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Doctor'S Research Group, Inc. is 188 days.
Which FDA product codes appear under Doctor'S Research Group, Inc.?
The most frequent FDA product codes under this applicant name are DQD (Stethoscope, Electronic, 2); DZL (Screw, Fixation, Intraosseous, 2); DYX (Lock, Wire, And Ligature, Intraoral, 1).
Next steps
- See all 13 Doctor'S Research Group, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DQD, Doctor'S Research 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.