Pressure Infusor
510(k) K881977
Pressure Infusor is a medical device (FDA Class I; FDA product code KZD, Infusor, Pressure, For I.V. Bags) made by Primrose Medical, Inc., cleared under FDA 510(k) K881977 on 29 Jul 1988, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK881977 | Date29 Jul 1988 | StatusActive |
Official records
- FDA 510(k) database K881977
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KZD
- Device class
- Class I
- Regulation
- 21 CFR Part 880.5420
- Advisory committee
- General Hospital
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code KZD (Infusor, Pressure, For I.V. Bags).
- PRESSURE INFUSION CUFF by Circulatory Technology, Inc.
- PRESSURE INFUSER by David Clark Company, Inc.
- SOLUTION ADMINISTRATION SET (#2C0631) by Travenol Laboratories, S.A.
- NORFOLK/NORWICH PRESSURE INFUSION BOX by Medical Innovations Corp.
- OLYMPUS AUTOMATIC SURGICAL IRRIGATION PUMP by Olympus America, Inc.
- INFUSION ACCELERATOR by Terumo America, Inc.
- BIOCUFF INFUSION BAG PRESSOR by Bio-Medical Instruments, Ltd.
- AUTOMATIC SHUT-OFF VALVE by Delta Medical Industries
- INJECTION SYSTEM, MDC I.V. by Medical Development Co.
- KAWASUMI LABORATORIES K-CUFF by Kawasumi Laboratories Co., Ltd.