FDA Tracker
Every imaging 510(k), the day FDA posts it.
Live from openFDA. Refreshed daily. Free, no account, no rate limit. Drop any clearance into Compass as a predicate candidate when you have a tenant.
510(k)
Sponsor
Class
Cleared
K253582
Apple, Inc.
I
2026-04-01
K171928
Med-Hot Thermal Imaging, Inc.
I
2017-12-08
K123408
Digirad Corp.
I
2013-01-15
K111791
Gamma Medica-Ideas Incorporated
I
2011-09-23
K100838
Digirad Corp.
I
2010-04-23
K081757
Verista Imaging, Inc.
I
2008-08-15
K063047
Medhot Thermal Imaging, Inc.
I
2006-10-19
K051402
Gvi Technology Partners
I
2005-06-13
K042733
Standard Imaging, Inc.
I
2004-11-15
K032471
Titronics Research & Development Co.
I
2003-10-10
K030165
Thermatrek
I
2003-04-16
K023373
Gvi Technology Partners
I
2003-01-03
K982112
Thermatrek, Inc.
I
1998-08-20
K974130
Dejarnette Research Systems
I
1998-01-29
K974102
Mitra Imaging, Inc.
I
1998-01-20
K973959
Olicon Imaging Systems, Inc.
I
1997-12-22
K973793
Olicon Imaging Systems, Inc.
I
1997-12-17
K973463
O Tech, Inc.
I
1997-12-02
K970652
Mitra Imaging, Inc.
I
1997-05-02
K962699
Applicare Medical Imaging, B.V.
I
1996-08-19
K950630
Wallach Surgical Devices, Inc.
I
1995-11-22
K953080
Camtronics, Ltd.
I
1995-09-28
K951175
Sirius Corp.
I
1995-06-30
K943383
Brit Systems, Inc.
I
1994-11-22
K941203
Cemco, Inc.
I
1994-06-27
K934731
Medsurg Industries, Inc.
I
1994-03-28
K940539
Standard Imaging, Inc.
I
1994-03-16
K926166
Optik
I
1993-06-01
K924178
Evergreen Technologies, Inc.
I
1993-02-02
K922164
Olicon Imaging Systems, Inc.
I
1993-01-21
K911691
Med-Tron Products, Inc.
I
1991-08-09
K912135
Med-Tron Products, Inc.
I
1991-07-17
K912181
Med-Tron Products, Inc.
I
1991-07-17
K911564
Med-Tron Products, Inc.
I
1991-07-15
K911561
Med-Tron Products, Inc.
I
1991-07-15
K903988
Med-Tron Products, Inc.
I
1990-10-23
K902230
Honeywell, Inc.
I
1990-06-19
K901118
Adac Laboratories
I
1990-04-10
K897186
Innovision Medical, Inc.
I
1990-03-12
K893826
Qrsystems, Inc.
I
1989-08-02
K885327
Philips Medical Systems North America, Inc.
I
1989-05-11
K884434
Vortech Data, Inc.
I
1989-01-19
K875198
Medasys, Inc.
I
1988-07-01
K862414
Parexel Intl. Corp.
I
1987-02-26
K870039
Par Microsystems Corp.
I
1987-02-12
K861534
Mitek , Inc.
I
1986-07-18
K853754
Victoreen, Inc.
I
1986-05-07
K860736
Fischer Imaging Corp.
I
1986-04-17
K850749
Concept, Inc.
I
1985-05-20
K850534
Bales Scientific, Inc.
I
1985-02-27
K840698
Powers Chemco, Inc.
I
1984-03-16
K811187
Medtronic Vascular
I
1981-05-27
K790629
Eastman Kodak Company
I
1979-04-23
K781500
Quinton, Inc.
I
1978-09-14
K780993
Boehringer Mannheim Corp.
I
1978-08-10
K771223
Eastman Kodak Company
I
1977-07-14
live · openFDA · refreshed daily
Want this dataset, AI-summarized?
Compass turns these into substantial-equivalence tables.
Pick three predicates from this list, paste their K-numbers into Compass, and get a draft SE comparison against your device in under a minute. The same RIG that powers the agent above.
Try the sandbox