Invacare Corp.: FDA filings under this applicant name
FDA lists 131 510(k) clearances under the applicant name “Invacare Corp.” (first 1980, latest 2021), across 20 product codes in 5 review panels. Median 510(k) review time under this name: 82 days. Since 2017 the median was 141 days, against 186 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 1 | 191 |
| 2016 | 5 | 92 |
| 2017 | 2 | 175 |
| 2018 | 2 | 126 |
| 2019 | 1 | 120 |
| 2020 | 2 | 132 |
| 2021 | 2 | 188 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Invacare Corp. took a median 141 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 186 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ITI | Wheelchair, Powered | 38 | 38 |
| IOR | Wheelchair, Mechanical | 32 | 32 |
| CAW | Generator, Oxygen, Portable | 20 | 20 |
| BXB | Exerciser, Powered | 8 | 8 |
| BZD | Ventilator, Non-Continuous (Respirator) | 5 | 5 |
| INI | Vehicle, Motorized 3-Wheeled | 5 | 5 |
| CAF | Nebulizer (Direct Patient Interface) | 4 | 4 |
| INO | Chair, Positioning, Electric | 4 | 4 |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 2 | 2 |
| FNL | Bed, Ac-Powered Adjustable Hospital | 2 | 2 |
Plus 10 more product codes.
Review panels
- Physical Medicine (90)
- Anesthesiology (35)
- General Hospital (4)
- Cardiovascular (1)
- Clinical Toxicology (1)
Most recent Invacare Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K203210 | Invacare Platinum 5NXG Oxygen Concentrator | CAW | 2021-04-12 | 164 |
| K202379 | Invacare AVIVA Storm RX Power Chair | ITI | 2021-03-19 | 211 |
| K200890 | Invacare Perfecto2V Oxygen Concentrator | CAW | 2020-08-06 | 125 |
| K192216 | Invacare AVIVA FX Power Wheelchair, Model: IFX-20MP | ITI | 2020-01-02 | 140 |
| 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 | CAW | 2019-08-29 | 120 |
| K182946 | Invacare TDX SP2-HD with Captain's Seat | ITI | 2018-12-11 | 49 |
| K181090 | Invacare® Solara® 3G and Solara® 3G Spree Manual Wheelchairs | IOR | 2018-11-14 | 203 |
| 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 | ITI | 2017-07-12 | 141 |
| K162621 | Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer IV Heavy Duty/Extra Wide Manual Wheelchair | IOR | 2017-04-17 | 209 |
| K162696 | Kuschall Advance Manual Wheelchair | IOR | 2016-12-28 | 92 |
121 earlier clearances. See the full list in Caduvo.
Recalls
68 product recalls in 51 recall events; 7 initiated in the last five years. Most recent: 2024-01-22.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Invacare Corp. (a text match, not an official crosswalk):
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Invacare Respiratory Corp. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Invacare Corp.?
FDA lists 131 510(k) clearances under the applicant name “Invacare Corp.” (first 1980, latest 2021), across 20 product codes in 5 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Invacare Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Invacare Corp. is 82 days. Since 2017: 141 days, versus 186 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Invacare Corp.?
The most frequent FDA product codes under this applicant name are ITI (Wheelchair, Powered, 38); IOR (Wheelchair, Mechanical, 32); CAW (Generator, Oxygen, Portable, 20).
Next steps
- See all 131 Invacare Corp. clearances with predicates and recalls
- Run predicate analysis for product code ITI, Invacare Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.