Atlas FDA

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

Invacare Corporation — Predicate Candidate Screening

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

125 daysmedian FDA review time
209 days90th percentile
20clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K203210Invacare Platinum 5NXG Oxygen ConcentratorInvacare Corporation2021-04-121640
K202379Invacare AVIVA Storm RX Power ChairInvacare Corporation2021-03-192110
K200890Invacare Perfecto2V Oxygen ConcentratorInvacare Corporation2020-08-061250
K192216Invacare AVIVA FX Power Wheelchair, Model: IFX-20MPInvacare Corporation2020-01-021400
K191159Concentrator with Single battery pack, carry bag with shouldInvacare Corporation2019-08-291200
K182946Invacare TDX SP2-HD with Captain's SeatInvacare Corporation2018-12-11490
K181090Invacare® Solara® 3G and Solara® 3G Spree Manual WheelchairsInvacare Corporation2018-11-142030
K170507Invacare® TDX® SP2 Power Wheelchair; TDXSP2 TDX SP2 with LiNInvacare Corporation2017-07-121410
K162621Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer IV HeInvacare Corporation2017-04-172090
K162692Kuschall K-Series Attract Manual WheelchairInvacare Corporation2016-12-28920
K162696Kuschall Advance Manual WheelchairInvacare Corporation2016-12-28920
K162686Kuschall Champion Manual WheelchairInvacare Corporation2016-12-28920
K160630Invacare Platinum Mobile Oxygen ConcentratorInvacare Corporation2016-09-272040
K152536MyOn HC Manual WheelchairInvacare Corporation2016-01-051230
K141783TDX SP2 POWER WHEECHAIRInvacare Corporation2015-01-091910
K083751INVACARE TPOC PORTABLE CONCENTRATOR, MODEL TPOC100Invacare Corporation2009-05-211550
K073134A-SERIES INTEGRAL CONTROLLER, MODEL INT/DL40IInvacare Corporation2007-11-1690
K060582INVACARE TOPAZ BARIATRIC MANUAL WHEELCHAIRInvacare Corporation2006-03-1690
K042483INVACARE PRO, COMPACT AND PORTABLE DESKTOPInvacare Corporation2005-01-061150
K041072KUSCHALL CHAMPION, KUSCHALL COMPACT, KUSCHALL ULTRA-LIGHTInvacare Corporation2004-05-12160

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