FDA Medical Device 510k Clearances

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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

2019-07-30

Version

2019-07-30

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
DEN000001OHMEDA MEDICALDANIEL KOSEDNARP.O. BOX 7550MADISONWIUS53707-755053707-75502000-01-072000-01-11DENGANMRNANPost-NSEFalseOHMEDA INOVENT DELIVERY SYSTEM
K000001BOSTON SCIENTIFIC SCIMED, INC.RON BENNETT5905 NATHAN LN.MINNEAPOLISMNUS55442554422000-01-032000-06-05SESESUJCTSummarySUTraditionalFalseWALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP DELIVERY SYSTEM
DEN000002UROSURGE, INC.STEVEN J PREISS2660 CROSSPARK RD.CORALVILLEIAUS52241522412000-01-272000-02-09DENGGUNAMGUPost-NSEFalseUROSURGE PERCUTANEOUS SANS (STOLLER AFFERENT NERVE STIMULATOR) DEVICE
K000002USA INSTRUMENTS, INC.RONY THOMAS1515 DANNER DR.AURORAOHUS44202442022000-01-032000-02-23SESERAMOSSummaryRATraditionalFalseMAGNA 5000 PHASED ARRAY CTL SPINE COIL
K000003TORNIERDAVID W SCHLERF200 GREGORY LN.SUITE C-100PLEASANT HILLCAUS94523-338994523-33892000-01-032000-10-02SESEORJDCSummaryORTraditionalFalseTORNIER TOTAL ELBOW PROSTHESIS
DEN000004MAET INDUSTRIES, INC.WAYNE WITBECK4215 RENOAK COURTMISSISSAUGA, ONTARIOCAL5C 4K3L5C 4K32000-01-282000-02-29DENGANMZTANPost-NSEFalseQUICKAIR CHOKE RELIEVER, MODEL 59-001A
K000004DAIG CORP.PAUL CORNELISON14901 DEVEAU PLACEMINNETONKAMNUS55345-212655345-21262000-01-032000-11-29SESECVDYBSummaryCVTraditionalFalseALLIANCE LEFT HEART DELIVERY SYSTEM INTRODUCER, MODEL #407509
K000005DIAGNOSTIC PRODUCTS CORP.EDWARD M LEVINE5700 WEST 96TH ST.LOS ANGELESCAUS90045-559790045-55972000-01-032000-03-03SESETXLEGSummaryTXTraditionalFalseIMMULITE VALPROIC ACID, IMMULITE 2000 VALPROIC ACID, CATALOG # LKVA1, LKVA5 & L2KVA2, L2KVA6
DEN000006UROMETRICS, INC.PHILIP A MESSINA445 ETNA ST., SUITE 56ST. PAULMNUS55106551062000-04-272000-04-28DENGOBNBVOBPost-NSEFalseEROS-CLITORAL THERAPY DEVICE (CTD)
K000006DIAGNOSTIC PRODUCTS CORP.EDWARD M LEVINE5700 WEST 96TH ST.LOS ANGELESCAUS90045-559790045-55972000-01-032000-02-28SESETXDIPSummaryTXTraditionalFalseIMMULITE PHENYTOIN, IMMULITE 2000 PHENYTOIN, CATALOG # LKPN1, LKPN5 & L2KPN2, L2KPN6