Stryker Medical: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Stryker Medical” (first 1991, latest 2023), across 9 product codes in 4 review panels. Median 510(k) review time under this name: 99 days. Since 2017 the median was 127 days, against 115 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.
Caduvo groups this applicant name under Stryker, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 479 |
| 2017 | 1 | 90 |
| 2018 | 1 | 133 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 127 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Stryker Medical took a median 127 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 115 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FPO | Stretcher, Wheeled | 4 | 4 |
| DWJ | System, Thermal Regulating | 3 | 3 |
| DWI | Saw, Electrically Powered | 1 | 1 |
| FNL | Bed, Ac-Powered Adjustable Hospital | 1 | 1 |
| FNM | Mattress, Air Flotation, Alternating Pressure | 1 | 1 |
| FQO | Table, Operating-Room, Ac-Powered | 1 | 1 |
| ILK | Transport, Patient, Powered | 1 | 1 |
| INM | Chair, With Casters | 1 | 1 |
| IOG | Treadmill, Mechanical | 1 | 1 |
Review panels
Most recent Stryker Medical 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K222818 | Xpedition Powered Stair Chair (625700000000) | ILK | 2023-01-24 | 127 |
| K180834 | Altrix Precision Temperature Management System | DWJ | 2018-08-10 | 133 |
| K171149 | Altrix Temperature Management Wraps | DWJ | 2017-07-18 | 90 |
| K152266 | Altrix Precision Temperature Management System | DWJ | 2016-12-02 | 479 |
| K113598 | POWER-LOAD COT FASTENER SYSTEM | FPO | 2011-12-20 | 15 |
| K946149 | STRYKER AGILITY INTENSIVE CARE BED | FNL | 1995-03-14 | 88 |
| K943864 | STRYKER 8000 SURGERY STRETCHER | FPO | 1994-08-25 | 17 |
| K935949 | STRYKER 5000 | FNM | 1994-06-17 | 186 |
| K941738 | STRYKER 5050 STRECHAIR | INM | 1994-05-06 | 29 |
| K940068 | STRYKER OPERATING ROOM TABLE | FQO | 1994-05-05 | 119 |
4 earlier clearances. See the full list in Caduvo.
Recalls
10 product recalls in 7 recall events; 0 initiated in the last five years. Most recent: 2006-01-17.
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.
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.
- Stryker Corp. (352 510(k)s)
- Stryker Endoscopy (102 510(k)s)
- Stryker Spine (75 510(k)s)
- Stryker Instruments (75 510(k)s)
- Stryker Sustainability Solutions (34 510(k)s)
- Stryker Neurovascular (33 510(k)s)
- Stryker Trauma AG (25 510(k)s)
- Stryker Orthopaedics (24 510(k)s)
- Stryker Leibinger GmbH & Co KG (22 510(k)s)
- Stryker Leibinger (13 510(k)s)
- Stryker Trauma GmbH (7 510(k)s)
- Stryker Corporate (6 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Stryker Medical?
FDA lists 14 510(k) clearances under the applicant name “Stryker Medical” (first 1991, latest 2023), across 9 product codes in 4 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 Stryker Medical?
The median time from FDA receipt to decision across 510(k)s cleared under the name Stryker Medical is 99 days. Since 2017: 127 days, versus 115 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Stryker Medical?
The most frequent FDA product codes under this applicant name are FPO (Stretcher, Wheeled, 4); DWJ (System, Thermal Regulating, 3); DWI (Saw, Electrically Powered, 1).
Next steps
- See all 14 Stryker Medical clearances with predicates and recalls
- Run predicate analysis for product code FPO, Stryker Medical'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.