510(k) · Cleared

Cleared

Infusion Dynamics Power Infuser

K974074510(k) TraditionalCleared Feb 17, 1998111-day reviewClass I21 CFR 880.5420

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Infusion Dynamics, Inc. · KZD Infusor, Pressure, For I.V. Bags

Cleared on Feb 17, 1998 after a 111-day review. FDA’s file for it is a 510(k) statement, which names no predicate.

Decided: Feb 17, 1998
Review: 111 days
Class: Class I
Product code: KZD
Recalls: None
Predicates: 0

FDA’s file for it is a 510(k) statement, which names no predicate.

FIG. 1 — Lineage of K974074Source: FDA 510(k) database · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KZD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All KZD devices

KZD Infusor, Pressure, For I.V. Bags: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KZD

FDA has decided no KZD device since 2007.

Median 510(k) review, days · KZD

Too few KZD 510(k)s in any year since 2007 to give a median.

Recalls per year · KZD

1in 2011

2007high 11 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KZD

41in 2025

2007high 72 (2014) · low 0 (2007)2025

MAUDE reports naming product code KZD, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	0
2008	—	11	3
2009	—	1	6
2010	—	0	9
2011	—	1	12
2012	—	0	1
2013	—	0	0
2014	—	0	72
2015	—	0	31
2016	—	0	4
2017	—	0	38
2018	—	0	6
2019	—	0	4
2020	—	0	8
2021	—	0	13
2022	—	0	45
2023	—	0	31
2024	—	0	43
2025	—	0	41
2026	—	0	—

What is it indicated for?

The ID Power Infuser™ is intended to support primary intravenous fluid resuscitation therapy to rapidly restore intravascular volume and blood pressure in patients with clinical shock, hypotension, and hypoperfusion states as a result of hemorrhagic blood loss, occult hemorrhage, neurogenic shock, and septic shock. The device is intended to be used by medical, paramedical, and EMT personnel in the field, and in pre-hospital and hospital environments. The…

Read the full statement (106 words)

The device is intended to be used by medical, paramedical, and EMT personnel in the field, and in pre-hospital and hospital environments.

The ID Power Infuser™ is intended to deliver crystalloid and colloid resuscitative fluids only. It is NOT intended to support the infusion of blood or blood products, nor is it intended for the delivery of any pharmaceutical or other medications.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K974074 · printed Nov 6, 2026

Cite this page

510(k) Report. “K974074: Infusion Dynamics Power Infuser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974074

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Page last updated Nov 3, 2026