Atlas FDA

IKE

15 FDA 510(k) clearances · Product code

57 daysmedian time to decision
333 days90th percentile
15clearances measured

FDA profile

Official device name
Transducer, Miniature Pressure
Device class
Class I (low risk)
Regulation
21 CFR 890.1615
Medical specialty
Physical Medicine
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
SONIC PALPOMETER (K060125)Palpometer Systems, Inc.2006-03-16
PRESSORE MONITOR (K954670)Cleveland Medical Devices, Inc.1995-10-30
THE EQUALIZER (K915369)Advanced Rehabilitative Technology, Inc.1993-03-22
PORTABLE LIMB LOAD MONITOR (BMLLM-100) (K915326)Bar Med Pty , Ltd.1992-10-20
IOWA ORAL PERFORMANCE ISNTRUMENT (K920091)Breakthrough, Inc.1992-05-20
FPL (K915897)Wrm Computers1992-04-07
TALLEY SD.500 SKIN PRESSURE EVALUATOR (K914780)Talley Group, Ltd.1991-12-19
MICRO-EMED-SYSTEM (K902967)Novel Electronics, Inc.1990-09-17
DYNATRON 2000 (K880912)Dynatronics Corp.1988-03-15
BIO-FEEDBACK LIMB MONITOR TYPE CODE BL-34-1 (K875103)Shield Computers , Ltd.1988-01-20
EMED-F-SYSTEM (K871690)Novel GmbH1987-05-15
PODOSCOPE (K864499)Broadwest Corp.1987-02-04
PODODIGITAL (K864569)Broadwest Corp.1987-02-04
MOSS LIMB LOAD MONITOR LM101-1 (K844202)Moss Rehabilation Hospital1984-11-27
ASC 4080 SYSTEM (K843634)Atlantis Scientific Corp.1984-11-08

Track IKE automatically

Every clearance here is in the API, with alerts when new ones post.