FDA 510(k) Scraper: Medical Device Clearances | $1/1K
Pricing
from $1.00 / 1,000 results
$1 per 1,000 results, platform usage included. FDA 510(k) medical device clearances from openFDA: K number, device, applicant, decision, dates, product code, class, panel and address. Filter by device, applicant, code or date. No key.
K number
kNumber
Optional
FDA premarket notification number. K is a 510(k), BK a 510(k) cleared by CBER, DEN a De Novo.
Device name
deviceName
Optional
Trade name of the cleared device.
Applicant
applicant
Optional
Manufacturer of record or the company that submitted the 510(k).
Decision date
decisionDate
Optional
Date FDA made its final decision.
Decision code
decisionCode
Optional
Four letter FDA decision code, for example SESE for substantially equivalent.
Decision
decisionDescription
Optional
The decision code in words, as openFDA gives it. Some De Novo records carry the text Unknown.
Date received
dateReceived
Optional
Date the FDA Document Control Center received the submission.
Days to decision
reviewDays
Optional
Whole days from date received to decision date. Worked out by this actor from the two dates.
Product code
productCode
Optional
Three letter FDA product code for the device category.
Clearance type
clearanceType
Optional
How the 510(k) was submitted, for example Traditional, Special, Direct or Dual Track.
Advisory committee code
advisoryCommittee
Optional
Two letter code of the medical specialty panel that classified the device.
Advisory committee
advisoryCommitteeDescription
Optional
Name of the medical specialty panel.
Review panel
reviewPanel
Optional
Code of the FDA review panel for the 510(k).
Statement or summary
statementOrSummary
Optional
Whether a 510(k) summary or a 510(k) statement was provided.
Third party review
thirdPartyReview
Optional
Y when the device is eligible for review by an accredited person, N when it is not.
Expedited review
expeditedReview
Optional
Flag for priority review by CDRH, as given by openFDA. Often empty.
Device class
deviceClass
Optional
Risk class: 1, 2 or 3. U is unclassified.
Regulation number
regulationNumber
Optional
Classification regulation numbers from 21 CFR.
Medical specialty
medicalSpecialty
Optional
Medical specialty of the classification regulation. Class 3 devices usually have none.
Address line 1
address1
Optional
Applicant delivery address, first line.
Address line 2
address2
Optional
Applicant delivery address, second line.
City
city
Optional
Applicant city.
State
state
Optional
Applicant state, for applicants in the United States.
Postal code
postalCode
Optional
Applicant postal or ZIP code.
Country code
countryCode
Optional
Applicant country code.
FDA page
url
Optional
The record in FDA's 510(k) database.
Source
source
Optional
Where the record comes from.
