Atlas FDA

Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

Quality Electrodynamics, LLC — Predicate Candidate Screening

21 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

56 daysmedian FDA review time
84 days90th percentile
21clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K242006SureWave Elastography (Q7000225)Quality Electrodynamics, LLC2025-02-122180
K223429Contour KneeQuality Electrodynamics, LLC2023-01-13600
K200477Flex Body SpeederQuality Electrodynamics, LLC2020-04-08410
K193140Flex Body SPEEDERQuality Electrodynamics, LLC2020-01-03510
K183111Contour 24Quality Electrodynamics, LLC2018-12-07290
K18169716ch Foot/ Ankle SPEEDERQuality Electrodynamics, LLC2018-07-11140
K17346916ch T/R Hand Wrist CoilQuality Electrodynamics, LLC2018-01-09620
K173446Contour 24Quality Electrodynamics, LLC2017-11-17110
K1629468ch Knee-Foot SPEEDERQuality Electrodynamics, LLC2017-01-06770
K16262316ch T/R Hand Wrist CoilQuality Electrodynamics, LLC2016-12-09800
K162966TxRx Knee 15 Flare MR Coil 1.5TQuality Electrodynamics, LLC2016-11-30370
K163066TxRx Knee 15 Flare MR Coil 3.0TQuality Electrodynamics, LLC2016-11-29270
K16202916ch T/R Knee CoilQuality Electrodynamics, LLC2016-10-18880
K16119316ch Tx/Rx Knee SPEEDERQuality Electrodynamics, LLC2016-06-02360
K1526958 CH Knee SPEEDERQuality Electrodynamics, LLC2015-11-18580
K15175316 ch Tx/Rx Knee SPEEDERQuality Electrodynamics, LLC2015-08-27590
K151829Atlas SPEEDER Header/NeckQuality Electrodynamics, LLC2015-07-29230
K15033118ch T/R Knee CoilQuality Electrodynamics, LLC2015-04-09580
K142802Atlas SPEEDER Head/NeckQuality Electrodynamics, LLC2014-11-24560
K142002BREAST SPEEDER CX, GRID HOLDER CXQuality Electrodynamics, LLC2014-08-22300
K140998PEDIATRIC 16, A1.5T TIM COIL/PEDIATRIC 16, A3T TIM COILQuality Electrodynamics, LLC2014-07-11840

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