Medical Innovations Corp.: FDA filings under this applicant name

FDA lists 24 510(k) clearances under the applicant name “Medical Innovations Corp.” (first 1979, latest 1995), across 7 product codes in 5 review panels. Median 510(k) review time under this name: 90 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
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Top product codes

Product codeDeviceSubmissions510(k) clearances
KNTTubes, Gastrointestinal (And Accessories)1818
BTXBoard, Arm (With Cover), Sterile11
FMFSyringe, Piston11
GFOActivated Partial Thromboplastin11
GKNTimer, Clot, Automated11
JAYSupport, Breathing Tube11
KZDInfusor, Pressure, For I.V. Bags11

Review panels

Most recent Medical Innovations Corp. 510(k) clearances

510(k)DeviceProduct codeDecision dateReview days
K945612MIC NASOGASTRIC-GASTROJEJUNAL FEEDING TUBEKNT1995-04-19155
K940548MIC PERCUTANEOUS ENDOSCOPIC JEJUNAL FEEDING TUBEKNT1995-02-22380
K943685MIC DISPOSABLE SNAREKNT1994-11-0195
K926581MIC TRANSGASTRIC JEJUNAL TUBEKNT1994-09-28727
K921652MIC TRANSGASTRIC JEJUNAL FEEDING TUBE KITKNT1994-05-02756
K921370MIC GASTRO-ENTEROSTOMY TUBE MODIFICATIONKNT1994-05-02773
K924065MIC PEG TUBEKNT1994-02-17570
K922667MIC LOW PROFILE GASTROSTOMY TUBEKNT1993-12-01597
K913320MIL CM-II COAGULATION MACHINEGKN1992-06-16327
K903531ANTICARDIOLIPIN ANTIBODY TEST SYSTEMGFO1991-01-25172

14 earlier clearances. See the full list in Caduvo.

Recalls

openFDA lists no recalls under a recalling firm named Medical Innovations Corp..

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.

Frequently asked questions

How many FDA 510(k) clearances are listed under Medical Innovations Corp.?

FDA lists 24 510(k) clearances under the applicant name “Medical Innovations Corp.” (first 1979, latest 1995), across 7 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 Medical Innovations Corp.?

The median time from FDA receipt to decision across 510(k)s cleared under the name Medical Innovations Corp. is 90 days.

Which FDA product codes appear under Medical Innovations Corp.?

The most frequent FDA product codes under this applicant name are KNT (Tubes, Gastrointestinal (And Accessories), 18); BTX (Board, Arm (With Cover), Sterile, 1); FMF (Syringe, Piston, 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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