Med General: FDA filings under this applicant name

FDA lists 12 510(k) clearances under the applicant name “Med General” (first 1977, latest 1979), across 10 product codes in 5 review panels. Median 510(k) review time under this name: 18 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

YearClearancesMedian review days
20120—
20130—
20140—
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Top product codes

Product codeDeviceSubmissions510(k) clearances
GDJClamp, Surgical, General & Plastic Surgery22
GXYElectrode, Cutaneous22
BXNStimulator, Nerve, Battery-Powered11
DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)11
DXCClamp, Vascular11
GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered11
GZJStimulator, Nerve, Transcutaneous, For Pain Relief11
IPFStimulator, Muscle, Powered11
ISBStimulator, Muscle, Diagnostic11
KDCInstrument, Surgical, Disposable11

Review panels

Most recent Med General 510(k) clearances

510(k)DeviceProduct codeDecision dateReview days
K791097CEPTORTRODE WITH CEPTOR HESIVEGXY1979-08-0352
K791098SINGLE-USE MINI-BULLDOGDXC1979-06-2210
K790763MAXI-VAC TMGCY1979-04-235
K790269CEPTOR HESIVEGXY1979-02-2621
K782006MEDGENERAL SINGLE-USE BULLDOGGDJ1978-12-1514
K781239MYO-STIMIPF1978-11-03106
K780632MAXICEPTORISB1978-08-14119
K780698STIMULATORS, NERVE, ELECTRICALGZJ1978-05-1216
K780117CARDIOMETERDRT1978-02-0311
K771702VESSEL-STABILIZERKDC1977-12-1396

2 earlier clearances. See the full list in Caduvo.

Recalls

openFDA lists no recalls under a recalling firm named Med General.

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 Med General?

FDA lists 12 510(k) clearances under the applicant name “Med General” (first 1977, latest 1979), across 10 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 Med General?

The median time from FDA receipt to decision across 510(k)s cleared under the name Med General is 18 days.

Which FDA product codes appear under Med General?

The most frequent FDA product codes under this applicant name are GDJ (Clamp, Surgical, General & Plastic Surgery, 2); GXY (Electrode, Cutaneous, 2); BXN (Stimulator, Nerve, Battery-Powered, 1).

Next steps

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.

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