Midas Rex Pneumatic Tools, Inc.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Midas Rex Pneumatic Tools, Inc.” (first 1985, latest 1997), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 54 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 |
|---|---|---|---|
| GET | Motor, Surgical Instrument, Pneumatic Powered | 5 | 5 |
| HBB | Motor, Drill, Pneumatic | 3 | 3 |
| ERL | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | 1 | 1 |
| HBE | Drills, Burrs, Trephines & Accessories (Simple, Powered) | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Midas Rex Pneumatic Tools, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K972289 | MIDAS REX MOTOR | HBB | 1997-09-12 | 85 |
| K970965 | MIDAS REX III MOTOR AND ATTACHMENTS (MIDAS III) | ERL | 1997-04-09 | 23 |
| K962483 | MIDAS REX III MOTOR | HBB | 1996-11-19 | 146 |
| K953434 | MIDAS REX MOTORS, (MIDAS I, MIDAS II & CONVERTIBLE MODELS) | HBB | 1996-05-16 | 300 |
| K954076 | MIDAS REX DRILL ATTACHMENTS & TWIST DRILLS | GET | 1995-10-18 | 49 |
| K953433 | MIDAS REX TELESCOPING SYSTEM | GET | 1995-09-15 | 56 |
| K953432 | ROTATING, FIXED FOOTED, FIXED SHIELD ATTACHMENTS, DISSECTING TOOLS | GET | 1995-09-14 | 55 |
| K952463 | GS & GS20 SURGICAL TOOL SYSTEM | GET | 1995-07-17 | 52 |
| K952300 | MIDAS REX MOTORS (MIDAS I, II & CONVERTIBLE MODELS) | GET | 1995-05-26 | 10 |
| K900388 | MODIFIED STERILIZATION OF DRILLS, BURRS, TREPHINES | HBE | 1990-05-07 | 98 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Midas Rex Pneumatic Tools, 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.
- Midas Intl. Development Corp. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Midas Rex Pneumatic Tools, Inc.?
FDA lists 12 510(k) clearances under the applicant name “Midas Rex Pneumatic Tools, Inc.” (first 1985, latest 1997), across 5 product codes in 3 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 Midas Rex Pneumatic Tools, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Midas Rex Pneumatic Tools, Inc. is 54 days.
Which FDA product codes appear under Midas Rex Pneumatic Tools, Inc.?
The most frequent FDA product codes under this applicant name are GET (Motor, Surgical Instrument, Pneumatic Powered, 5); HBB (Motor, Drill, Pneumatic, 3); ERL (Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece, 1).
Next steps
- See all 12 Midas Rex Pneumatic Tools, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GET, Midas Rex Pneumatic Tools, 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.