DeviceSignal · 510(k) cleared
PRIMED Medical Products, Inc.
FDA 510(k) decision recorded 2026-09-01 · K261811 · Traditional 510(k)
Event510(k) cleared
Effective2026-09-01
DecisionSESE
On 2026-09-01 the FDA recorded a 510(k) clearance decision for PRIMED Medical Products, Inc., for PRIMED Chemotherapy Drug Tested Gowns (PM4-99450: PRIMED Chemotherapy Drug Tested…. Clearance K261811. Product code QSO. A clearance is a regulatory decision, not an endorsement of the device.
Reported facts
- 510(k) number
- K261811
- Applicant
- PRIMED Medical Products, Inc.
- Device
- PRIMED Chemotherapy Drug Tested Gowns (PM4-99450: PRIMED Chemotherapy Drug Tested Isolation Gown, Purple, AAMI Level 2; PM4-99460: PRIMED Chemotherapy Drug Tested Isolation Gown, Blue, AAMI Level 3)
- Decided on
- 2026-09-01
- Received on
- 2026-06-01
- Decision
- SESE
- Clearance type
- Traditional
- Product code
- QSO
- Review days
- 92
Every field above is as fda_device_510k published it. Nothing on this page is our interpretation.
Provenance
- Source
- fda_device_510k
- Source record
K261811- Snapshot hash
20a5eca6af1b369a7deac34e4dde0974506cc835c24e3cb66b330d9671a11814- Source URL
- https://download.open.fda.gov/device/510k/device-510k-0001-of-0001.json.zip
- Observed
- 2026-09-15T12:38:10.708Z
- Transform
fda_device_510k_to_clearance v1- Event rule
fda_device_510k_cleared v1- Event key
306bfdf4be614d87d842c83b32cacba65cfb71cf68c62ec2c5cef50bbacbee81- Signal type
device_clearance.granted
Source terms that apply
- This is not a public alerting service and must not be used to notify patients or the public
- We do not report whether a recall is still open; FDA does not maintain that after classification
- Nothing here is a medical or clinical decision aid
- Not affiliated with, endorsed by, or certified by the FDA
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov)