General Medical Co.: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “General Medical Co.” (first 1977, latest 1993), across 12 product codes in 5 review panels. Median 510(k) review time under this name: 59 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 |
|---|---|---|---|
| EGJ | Device, Iontophoresis, Other Uses | 2 | 2 |
| FRG | Wrap, Sterilization | 2 | 2 |
| KMJ | Lubricant, Patient | 2 | 2 |
| BSY | Catheters, Suction, Tracheobronchial | 1 | 1 |
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 1 | 1 |
| EFQ | Gauze/Sponge, Internal | 1 | 1 |
| FHX | Jelly, Lubricating, For Transurethral Surgical Instrument | 1 | 1 |
| FME | Gown, Examination | 1 | 1 |
| FSM | Tray, Surgical, Instrument | 1 | 1 |
| FYC | Gown, Isolation, Surgical | 1 | 1 |
Plus 2 more product codes.
Review panels
- General Hospital (7)
- General and Plastic Surgery (3)
- Anesthesiology (2)
- Physical Medicine (2)
- Gastroenterology and Urology (1)
Most recent General Medical Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K926269 | PROCEDURE KIT | LRO | 1993-08-27 | 252 |
| K912975 | OPERAND LUBRICATING JELLY | KMJ | 1991-09-27 | 81 |
| K912132 | OPERAND LUBRICATING JELLY | FHX | 1991-08-07 | 85 |
| K903669 | GENESIS INSUFFLATING CATHETER | BSY | 1990-09-12 | 30 |
| K900110 | OPERAND* LUBRICATING JELLY | KMJ | 1990-05-02 | 113 |
| K853635 | SUBDERM TM | EGJ | 1985-12-20 | 112 |
| K844652 | C.A.S.E. CONTAINER | FSM | 1984-12-12 | 13 |
| K831320 | DRIONIC | EGJ | 1983-07-19 | 88 |
| K820689 | C.S.R. WRAPPERS | FRG | 1982-04-09 | 28 |
| K820521 | STERILIZATION WRAP | FRG | 1982-03-18 | 20 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named General Medical Co..
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.
- General Electric Co. (254 510(k)s)
- General Diagnostics (39 510(k)s)
- General Electric Medical Systems Information Techn (33 510(k)s)
- General Biometrics, Inc. (23 510(k)s)
- General Surgical Innovations (14 510(k)s)
- General X-Ray, Inc. (14 510(k)s)
- General Devices (13 510(k)s)
- General Physiotherapy, Inc. (9 510(k)s)
- General Medical Merate S.P.A (7 510(k)s)
- General Theraphysical, Inc. (7 510(k)s)
- General Atomics (6 510(k)s)
- General Electric Medical Systems (6 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under General Medical Co.?
FDA lists 15 510(k) clearances under the applicant name “General Medical Co.” (first 1977, latest 1993), across 12 product codes in 5 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 General Medical Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name General Medical Co. is 59 days.
Which FDA product codes appear under General Medical Co.?
The most frequent FDA product codes under this applicant name are EGJ (Device, Iontophoresis, Other Uses, 2); FRG (Wrap, Sterilization, 2); KMJ (Lubricant, Patient, 2).
Next steps
- See all 15 General Medical Co. clearances with predicates and recalls
- Run predicate analysis for product code EGJ, General Medical Co.'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.