Atlas FDA

KZD

35 FDA 510(k) clearances · Product code

48 daysmedian time to decision
150 days90th percentile
35clearances measured

FDA profile

Official device name
Infusor, Pressure, For I.V. Bags
Device class
Class I (low risk)
Regulation
21 CFR 880.5420
Medical specialty
General Hospital
Adverse events (MAUDE)
2021: 13 · 2022: 45 · 2023: 31 · 2024: 43 · 2025: 41 · 2026: 12
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
INFUSION DYNAMICS POWER INFUSER (K974074)Infusion Dynamics, Inc.1998-02-17
MSI PRESSURE INFUSOR (K973843)Smith Assoc.1997-10-29
OLYMPUS AUTOMATIC SURGICAL IRRIGATION PUMP (K953290)Olympus America, Inc.1995-10-07
PRESSURIZER (K951988)Promedic, Inc.1995-06-14
PRESSURE INFUSION CUFF (K942933)Circulatory Technology, Inc.1994-08-25
KAWASUMI LABORATORIES K-CUFF (K930012)Kawasumi Laboratories Co., Ltd.1993-12-14
ALLEN INFUSION PUMP MODEL 3000 AND IRRIGATION 2000 (K921168)Allen Medical Systems, Inc.1993-04-21
PRESSURE INFUSER (K913751)Biomedical Dynamics, Inc.1992-01-09
TECNADYNE SURGI-SQUEEZE INFUSION PUMP (K910926)Tecnadyne Scientific, Inc.1991-08-02
INFUSABLE (K911216)Biomedical Dynamics, Inc.1991-07-22
BAXTER SINGLE PATIENT USE PRESSURE INFUSOR (K904484)Tecnadyne Scientific, Inc.1990-10-26
LIFE SHIELD (DISPOSABLE PRESSURE INFUSOR) (K901225)Abbott Laboratories1990-08-23
SURGI SQUEEZ (K894927)Ethox Corp.1989-09-11
PRESSURE INFUSOR (K881977)Primrose Medical, Inc.1988-07-29
IV-PUSH, CONSTANT INFUSION PUMP (K874454)Medical Products Search, Inc.1987-11-06
BIOMEDICAL DYNAMICS DISPOSABLE PRESSURE INFUSOR (K861977)Biomedical Dynamics, Inc.1986-07-15
LIFE PAC (K854807)Lifemed Technologies, Inc.1986-04-15
THE WOOD PUMP 'OLE RED' (K855054)T.C. Retigo, Inc.1986-03-18
PRESSURE INFUSOR #1900 (K860084)Pa Medical Corp.1986-03-18
DATA TRAC ANESTHESIOLOGY RECORDER (K851904)Datascope Corp.1985-05-10
BIOCUFF INFUSION BAG PRESSOR (K832377)Bio-Medical Instruments , Ltd.1983-08-12
CREST PRESSURE INFUSOR (K822434)Crest Medical Equipment1982-09-17
AUTOCUFF (PHOTOS ENCLOSED WITH 510K (K822286)Partamed, Inc.1982-08-27
PRESSURE INFUSER (K820159)David Clark Company, Inc.1982-04-21
PRESSURE INFUSION PUMP (K813105)Calbio, Inc.1981-12-14
NORFOLK/NORWICH PRESSURE INFUSION BOX (K810954)Medical Innovations Corp.1981-04-21
MX820-5 PRESSURE INFUSOR 500CC MX820-10 (K800560)Medex, Inc.1980-04-29
PRESSURE INFUSION DEVICE (K781037)Hinck Medical, Inc.1978-09-14
VOLUME CONTROL DEVICE VCD-150 (K780465)Sorensen Research1978-06-02
INFUSION ACCELERATOR (K771458)Terumo America, Inc.1977-08-26
INJECTION SYSTEM, MDC I.V. (K770758)Medical Development Co.1977-05-20
AUTOMATIC SHUT-OFF VALVE (K760895)Delta Medical Industries1976-12-09
BLOOD-SOLUTION ADMINISTRATION SET, SURG. (K760483)Travenol Laboratories, S.A.1976-09-03
SOLUTION ADMINISTRATION SET (#2C0631) (K760505)Travenol Laboratories, S.A.1976-09-03
KIT, PREP, INSPIRON IV (K760313)Inspiron Corp.1976-08-04

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Every clearance here is in the API, with alerts when new ones post.