510(k) Report

FDA applicant

Invacare Corp.

Elyria, OH131 decisions1980–202135 recalls

FDA records 131 decisions for Invacare Corp. (Elyria, OH) from 1980 to 2021: 131 510(k) clearances. Most are in product codes ITI (Wheelchair, Powered) and IOR (Wheelchair, Mechanical). Since 2016 its 510(k)s took a median of 125 days from receipt to decision, against 159 for FDA’s reviews in the same codes and years. Its devices cite 83 predicates, 44 of them its own earlier devices. 35 recalls are linked to its devices.

FDA’s records also spell it “Invacare Corporation”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, physical medicine panel, where it files most

How often FDA has decided Invacare Corp.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2021

2007: 32009: 12015: 12016: 52017: 22018: 22019: 12020: 22021: 2
2007high 5 (2016) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

2in 2022

2007: 22009: 22011: 12012: 32013: 12014: 32015: 42016: 22020: 12021: 32022: 2
2007high 4 (2015) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Invacare Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Invacare Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • ITIWheelchair, Powered38decisions
  • IORWheelchair, Mechanical32decisions
  • CAWGenerator, Oxygen, Portable20decisions
  • BXBExerciser, Powered8decisions
  • INIVehicle, Motorized 3-Wheeled5decisions
  • BZDVentilator, Non-Continuous (Respirator)5decisions

Also: CAF (4), INO (4), FNL (2), BTT (2), NFB (2), DPS (1).

How long do its 510(k) reviews take?

Since 2016, its 11 510(k)s took a median of 125 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 159 days; 8 of its 11 were faster than that.

Whose devices does it build on?

Its devices cite 83 predicates; 44 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 120 times; 44 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K935398Tracer Series Manual WheelchairsInvacare Corp. · 199412cite it
  • K003939Venture Home Fill II, Model Ioh 200Invacare Corp. · 20016cite it
  • K020386Invacare Platinum, Models Irc 5LX and Irc 5LX02Invacare Corp. · 20025cite it
  • K012370Solara JR. Manual WheelchairInvacare Corp. · 20014cite it
  • K991168Arrow FWD Power WheelchairInvacare Corp. · 19994cite it
  • K984447Model Action at II Manual WheelchairInvacare Corp. · 19994cite it

What has FDA decided for it lately?

  • K203210Invacare Platinum 5NXG Oxygen ConcentratorInvacare Corporation · 20211 recall
  • K202379Invacare AVIVA Storm RX Power ChairInvacare Corporation · 20211 recall
  • K200890Invacare Perfecto2V Oxygen ConcentratorInvacare Corporation · 20201 recall
  • K192216Invacare AVIVA FX Power Wheelchair, Model: IFX-20MPInvacare Corporation · 20201 recall
  • K191159Concentrator with Single battery pack, carry bag with shoulder strap, back pack shoulder straps, A, POC1 USB…Invacare Corporation · 2019
  • K182946Invacare TDX SP2-HD with Captain's SeatInvacare Corporation · 2018
  • K181090Invacare® Solara® 3G and Solara® 3G Spree Manual WheelchairsInvacare Corporation · 2018
  • K170507Invacare® TDX® SP2 Power Wheelchair; TDXSP2 TDX SP2 with LiNX Electronics, TDXSP2-CG TDX SP2 Base for Single…Invacare Corporation · 20172 recalls

All 111 as Invacare Corp. →All 20 as Invacare Corporation →

What has been recalled?

35 recalls linked to its devices; the latest:

  • K203210Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canada…Jun 10, 2022Class III
  • K170507Invacare TDX SP2, Model Nos. TDXSP2 TDXSP2-MCG TDXSP2VMar 30, 2022Class II
  • K202379Invacare AVIVA Storm RX with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model…Nov 12, 2021Class II
  • K192216Invacare AVIVA FX with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers…Nov 12, 2021Class II
  • K170507Invacare TDX SP2 with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers…Nov 12, 2021Class II
  • K200890Invacare PerfectO2 V Oxygen Concentrator- intended for patients with respiratory…Oct 30, 2020Class II

Other applicant names beginning “Invacare”

FDA records each applicant name separately; these may or may not be the same firm.

Invacare Respiratory Corp. 2