Prytime Medical Devices, Inc.
Prytime Medical Devices, Inc. appears in FDA public data with 2 recalls, 5 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-0959-2021, Class II) was initiated on December 14, 2020. Its most recent 510(k) clearance was granted on September 5, 2025.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 5
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0959-2021 | Class II | PRYTIME MEDICAL REBOA Catheter Introducer Kit, REF: KT1835C, Contents: Needle, 18 GA x 7 CM ECHOG | December 14, 2020 |
| Z-0716-2021 | Class II | PryTime Medical - ER-Reboa Plus Catheter, Ref: ER7232PLUS, Guidewire Free, Compatabel with 7Fr intro | October 29, 2020 |