FDA product code KZD: Infusor, Pressure, For I.V. Bags
KZD is the FDA product code for infusor, pressure, for i.v. bags. It is a Class I device, regulated under 21 CFR 880.5420 and reviewed by the General Hospital panel. FDA has cleared 35 510(k) submissions under KZD, from 31 different applicants. The average 510(k) review took 78 days (median 48). FDA has posted 14 recalls for KZD devices.
Classification
| Field | Value |
|---|---|
| Device name | Infusor, Pressure, For I.V. Bags |
| Device class | Class I |
| Regulation | 21 CFR 880.5420 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KZD clearance
Top KZD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Biomedical Dynamics, Inc. | 3 | 1992-01-09 |
| Tecnadyne Scientific, Inc. | 2 | 1991-08-02 |
| Travenol Laboratories, S.A. | 2 | 1976-09-03 |
| Infusion Dynamics, Inc. | 1 | 1998-02-17 |
| Smith Assoc. | 1 | 1997-10-29 |
26 more applicants have KZD clearances. See the full list in Caduvo.
Most recent KZD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K974074 | Infusion Dynamics, Inc. | INFUSION DYNAMICS POWER INFUSER | 1998-02-17 | 111 |
| K973843 | Smith Assoc. | MSI PRESSURE INFUSOR | 1997-10-29 | 21 |
| K953290 | Olympus America, Inc. | OLYMPUS AUTOMATIC SURGICAL IRRIGATION PUMP | 1995-10-07 | 85 |
| K951988 | Promedic, Inc. | PRESSURIZER | 1995-06-14 | 48 |
| K942933 | Circulatory Technology, Inc. | PRESSURE INFUSION CUFF | 1994-08-25 | 64 |
Recalls for KZD devices
14 product recalls in 4 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-05-22.
| Year | Recalls |
|---|---|
| 2017 | 1 |
Frequently asked questions
What is FDA product code KZD?
KZD is the FDA product code for infusor, pressure, for i.v. bags. It is a Class I device, regulated under 21 CFR 880.5420 and reviewed by the General Hospital panel.
What device class is KZD?
Class I, regulation 21 CFR 880.5420. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KZD?
Across 35 cleared submissions the average was 78 days from receipt to decision (median 48).
Which companies have the most KZD clearances?
Biomedical Dynamics, Inc. (3); Tecnadyne Scientific, Inc. (2); Travenol Laboratories, S.A. (2); Infusion Dynamics, Inc. (1); Smith Assoc. (1).
Have KZD devices been recalled?
Yes: 14 product recalls across 4 recall events; the most recent began 2017-05-22.
Next steps
- Run an FDA pathway report with predicate devices for product code KZD
- Run a recall and safety report across every KZD manufacturer
- Watch product code KZD for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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