# Invacare Corp.

- Location (FDA's records): Elyria, OH
- FDA decisions: 131 (1980–2021): 131 510(k) clearances
- Names in FDA's records: Invacare Corp. (111); Invacare Corporation (20)
- Product codes: ITI (38), IOR (32), CAW (20), BXB (8), INI (5), BZD (5), CAF (4), INO (4), FNL (2), BTT (2), NFB (2), DPS (1)
- 510(k) review time since 2016: median 125 days, against 159 for FDA's reviews in the same codes and years (8 of 11 faster)
- Predicates its devices cite: 83 (44 its own); citations of its devices by later devices: 120 (44 its own)
- Recalls linked to its devices: 35 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Permobil AB: 6 (https://510kreport.com/company/permobil)
- Respironics, Inc.: 4 (https://510kreport.com/company/respironics)
- Resmed, Ltd.: 3 (https://510kreport.com/company/resmed)
- Motion Concepts: 2 (https://510kreport.com/company/motion-concepts)
- Sunrise Medical, Inc.: 2 (https://510kreport.com/company/sunrise-medical)
- Top End Wheelchair Sports, Inc.: 2 (https://510kreport.com/company/top-end-wheelchair-sports)
- Project Marketing: 1 (https://510kreport.com/company/project-marketing)
- Medical Industries America, Inc.: 1 (https://510kreport.com/company/medical-industries-america)

## Firms that cite its devices most
- Merits Health Products Co., Ltd.: 3 (https://510kreport.com/company/merits-health-products)
- Panthera Production AB: 2 (https://510kreport.com/company/panthera-production)
- Invacare Respiratory Corp.: 2 (https://510kreport.com/company/invacare-respiratory)
- Pacific Consolidated Industries: 2 (https://510kreport.com/company/pacific-consolidated-industries)
- Sunrise Medical, Inc.: 2 (https://510kreport.com/company/sunrise-medical)
- Vestil Manufacturing Corp.: 2 (https://510kreport.com/company/vestil-manufacturing)
- Barton Medical Corp.: 2 (https://510kreport.com/company/barton-medical)
- Dynamic Systems, Inc.: 2 (https://510kreport.com/company/dynamic-systems)

## Its most-cited devices
- K935398: Tracer Series Manual Wheelchairs (1994), cited by 12
- K003939: Venture Home Fill II, Model Ioh 200 (2001), cited by 6
- K020386: Invacare Platinum, Models Irc 5LX and Irc 5LX02 (2002), cited by 5
- K012370: Solara JR. Manual Wheelchair (2001), cited by 4
- K991168: Arrow FWD Power Wheelchair (1999), cited by 4
- K984447: Model Action at II Manual Wheelchair (1999), cited by 4

## Recent decisions
- K203210: Invacare Platinum 5NXG Oxygen Concentrator (Apr 12, 2021)
- K202379: Invacare AVIVA Storm RX Power Chair (Mar 19, 2021)
- K200890: Invacare Perfecto2V Oxygen Concentrator (Aug 6, 2020)
- K192216: Invacare AVIVA FX Power Wheelchair, Model: IFX-20MP (Jan 2, 2020)
- K191159: Concentrator with Single battery pack, carry bag with shoulder strap, back pack shoulder straps, A, POC1 USB Bluetooth Dongle, POC1 Invacare Mobile Medical Application Accessory for use on iOS and Android Devices, Invacare Platinum Mobile Oxygen Concentrator with Connectivity (Aug 29, 2019)
- K182946: Invacare TDX SP2-HD with Captain's Seat (Dec 11, 2018)
- K181090: Invacare® Solara® 3G and Solara® 3G Spree Manual Wheelchairs (Nov 14, 2018)
- K170507: Invacare® TDX® SP2 Power Wheelchair; TDXSP2 TDX SP2 with LiNX Electronics, TDXSP2-CG TDX SP2 Base for Single Act. System w/ Ultra Low Maxx, TDXSP2-MCG TDX SP2 Base for Multiple Actuator System w/ Ultra Low Maxx (Jul 12, 2017)

Source page: https://510kreport.com/company/invacare