Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

KHX — Predicate Candidate Screening

15 FDA 510(k) clearances under this product code; the 50 most recent screened below.

90 daysmedian FDA review time
249 days90th percentile
15clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K951771COMMUNITY BALANCE PERFORMANCE MONITOR OR COMMUNITY BPMSms Technologies, Ltd.1995-08-111160
K946229BALANCE MANAGERNeurocom International, Inc.1995-08-042250
K942694STABILITY SYSTEM (110V) MODEL 945-300; STABILITY SYSTEM (220Biodex Medical Systems, Inc.1995-03-102760
K930089SMS BALANCE PERFORMANCE MONITORSms Technologies, Ltd.1993-06-081510
K921340FORCE MEASURING PLATFORMSra Intl., Inc.1992-05-26670
K901069COMPUTERIZED FUNCTIONAL TESTING GAIT SYSTEMComputerized Functional Testing Corp.1990-03-1690
K893254DYNAMIC SYSTEM COMPUTERIZED PODIATRIC ANALYZERDalphi, Inc.1990-01-022490
K883131BIOMECHANICS FORCE PLATFORM #LG6-4-1000 & 2000Advanced Mechanical Technology, Inc.1988-10-24900
K883130BIOMECHANICS FORCE PLATFORM/# OR6-5-1000 & 2000Advanced Mechanical Technology, Inc.1988-10-24900
K883129BIOMECHANICS FORCE PLATFORM/#OR 6-6-1000 & 2000Advanced Mechanical Technology, Inc.1988-10-24900
K883198BIOVEC BIOMECHANIC FORCE ANALYSIS SYSTEMAdvanced Mechanical Technology, Inc.1988-10-24880
K883127MULTI-CHANNEL STRAIN-GAGE AMPLIFIER & POWER SUPPLYAdvanced Mechanical Technology, Inc.1988-09-30660
K863443DUAL FORCEPLATENeurocom International, Inc.1986-09-17120
K821255ELECTRODYNOGRAM SYSTEMThe Langer Group1982-07-02630
K820444HEART-ALERTMedical Equipment Devices, Inc.1982-03-12220

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda