FDA Medical Device 510k Clearances

$447.50 / year

The Food and Drug Administration (FDA) Medical Device 510k Clearances dataset lists all (510(k)) submissions for medical devices. These are reviewed by FDA’s Center for Devices and Radiological Health (CDRH), specifically, by the Office of Device Evaluation (ODE) and the Office of In Vitro Diagnostics and Radiological Health (OIR). 510(k) submissions are reviewed by ODE and OIR staff, including biomedical engineers, physicians, microbiologists, chemists, and other scientific professionals.

Complexity

A 510(k) is required when:
– Introducing a device into commercial distribution (marketing) for the first time. After May 28, 1976 (effective date of the Medical Device Amendments to the Act), anyone who wants to sell a device in the U.S. is required to make a 510(k) submission at least 90 days prior to offering the device for sale, even though it may have been under development or clinical investigation before that date. If your device was not marketed by your firm before May 28, 1976, a 510(k) is required.
– You propose a different intended use for a device which you already have in commercial distribution. The 510(k) regulation (21 CFR 807) specifically requires a 510(k) submission for a major change or modification in intended use. Most, if not all changes in intended use will require a 510(k). Please note that prescription use to over the counter use is a major change in intended use and requires the submission of a new 510(k).
– There is a change or modification of a legally marketed device and that change could significantly affect its safety or effectiveness. The burden is on the 510(k) holder to decide whether or not a modification could significantly affect safety or effectiveness of the device. Any modifications must be made in accordance with the Quality System regulation, 21 CFR 820, and recorded in the device master record and change control records. It is recommended that the justification for submitting or not submitting a new 510(k) be recorded in the change control records.

The Expedited Review in this dataset is ‘Y’ for some of the records which indicates that the 510(k) was granted expedited review status for those records.

Date Created

2011

Last Modified

2018-12-14

Version

2018-12-14

Update Frequency

Quarterly

Temporal Coverage

N/A

Spatial Coverage

United States

Source

John Snow Labs; U.S. Food and Drug Administration (FDA);

Source License URL

Source License Requirements

N/A

Source Citation

N/A

Keywords

510k Device Clearances, Medical Devices, Medical Device Reviews, Medical Device Submissions

Other Titles

Medical Device 510k Submissions, 510k Device Submissions

NameDescriptionTypeConstraints
KNumberMedical device 510(K) submission numberstringrequired : 1
ApplicantApplicant namestringrequired : 1
ContactApplicant contact namestring-
Address_Line1The first line of the address of applicantstring-
Address_Line2The second line of the address of applicantstring-
CityCity of Applicantstring-
State_AbbreviationTwo-letter state of the applicantstring-
Country_CodeCountry of Applicantstringrequired : 1
Zip_CodeZip of Applicantstring-
Postal_CodePostal code of Applicantstring-
Date_ReceivedDate of submission receptiondaterequired : 1
Decision_DateFDA decision datedaterequired : 1
DecisionFDA decisionstringrequired : 1
Advisory_CommitteeThe Advisory committeestringrequired : 1
Product_CodeMedical device codestringrequired : 1
Statement_Or_SummarySTATEMENT indicates that safety and effectiveness information may be obtained from the 510(k) applicantstring-
Advisory_Committee_CodeAdvisory committee codestring-
TypeDenotes the type of 510(k) submission: Traditional, Special, Abbreviated, Evaluation of Automatic Class III Designationstringrequired : 1
Is_Third_PartyIndicates if the 510(k) was reviewed by a Third Partybooleanrequired : 1
Device_NameDevice namestring-
KNumberApplicantContactAddress_Line1Address_Line2CityState_AbbreviationCountry_CodeZip_CodePostal_CodeDate_ReceivedDecision_DateDecisionAdvisory_CommitteeProduct_CodeStatement_Or_SummaryAdvisory_Committee_CodeTypeIs_Third_PartyDevice_Name
K040757SIC INVENT AGGEORG SCHILLICH-4055BASELCH2004-03-252005-04-13SESEDEDZESummaryDETraditionalfalseSIC PRO
K152788EOS IMAGINGMATHIAS BREUIL10 RUE MERCOEURPARISFR2015-09-252015-10-21SESERAKPRSummaryRASpecialfalseEOS System
K113442SHINA SYSTEMS LTD.DAN LAOR6 SIRENIHAIFAIL32972329722011-11-212012-02-16SESERALLZSummaryRATraditionalfalse3DI
K093703SHINA SYSTEMS LTD.DAN LAORSIRENI 6,HAIFAIL32972329722009-12-012010-01-19SESERALLZSummaryRATraditionalfalse3DI
K133608BICON, LLCRICHARD WU501 ARBORWAYBOSTONMAUS213021302013-11-252014-03-14SESEDEEBFSummaryDEAbbreviatedfalseTRINIA
K152932ORIGIO A/STOVE KJAERKNARDRUPVEJ 2MALOVDK276027602015-10-052016-02-29SESEOBMQLSummaryOBTraditionalfalseBlastGen
K173381Barco n.v.Eric CausBeneluxpark 21KortrijkBE850085002017-10-302018-02-22SESECVDXJSummaryCVSpecialfalseNexxis OR
K971092SMITHE.J. SmithP.O. BOX 4341CROFTONMDUS21114211141997-03-261997-04-23SESESUGEIStatementSUTraditionalfalseQA-ES
K050561MEDCON LTD.ELI M ORBACHPOB 6718EFRATIL90435904352005-03-032005-05-04SESECVDQKSummaryCVTraditionalfalseWINDSURFER
K121817IVT MEDICAL LTDELI ORBACHPOB 6718EFRATIL91435914352012-06-202013-09-17SESESUOMPSummarySUTraditionalfalseVCARE A