510(k) · Cleared

Cleared

Power Infuser, Model M100B-3A

K090736510(k) TraditionalCleared May 20, 200962-day reviewClass II21 CFR 880.5725

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

ZOLL Medical Corporation · FRN Pump, Infusion

Cleared on May 20, 2009 as substantially equivalent to K030739 (Infusion Dynamics, Inc., 2004) and 1 other predicate after a 62-day review. Its family tree reaches back 1 generation to 1982. 1 later device descends from it.

Decided: May 20, 2009
Review: 62 days
Class: Class II
Product code: FRN
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K820159 (1982). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK820159 Pressure InfuserDavid Clark Company, Inc. · 1982
This deviceK090736 Power Infuser, Model M100B-3AZOLL Medical Corporation · 2009
Descendant · cites it directly · 0 of its ownK172653 Power InfuserZOLL Medical Corporation · 2018

Most influential descendants

Showing 1 of 1 · See all

K172653Power InfuserZOLL Medical Corporation · 2018 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K820159	Pressure Infuser	David Clark Company, Inc.	1982	—
0 (this device)	K090736	Power Infuser, Model M100B-3A	ZOLL Medical Corporation	2009	—
+1	K172653	Power Infuser	ZOLL Medical Corporation	2018	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2018	1	0

FIG. 1 — Lineage of K090736, 1982–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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

Top candidate predicates for a new FRN device

#1 K253703 RemunityPRO+ Pump for Remodulin®…score 12.6 · 4 generations · no Class I recall
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What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K030739	Infusion Dynamics (ID) Power Infuser, Model M100B-3A with Blood Cartridge Summary page 1 …ass 11 (21 CFR 880.5725) Reason for submission: Change in the Intended Use Description: The Power Infuser model M100B-3A, reviewed and cleared under (K030739) is a miniature battery-operated infusion pump designed to deliver IV fluids and blood products to patients in the field,…	Infusion Dynamics, Inc.	2004	1
*	K820159	Pressure Infuser Summary page 2 …kY16h36 V44c I Lr A previous 510(k) submissions demonstrated substancial equivalence to the David Clark Pressure Infuser for an I.V. bag (K820159 as required by 21 CFR Part 880.5420). The purpose of this submission is to more closely align the Intended Use of the Power…	David Clark Company, Inc.	1982	—

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K172653	Power Infuser	ZOLL Medical Corporation	2018	0

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.

What does this lineage say?

1 of the 2 ancestors has a recall of any class.
Of its descendants, K172653 (ZOLL Medical Corporation, 2018) has gone furthest, with 0 descendants of its own.

How does its category compare?

All FRN devices

FRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · FRN

8in 2025

2007high 12 (2007) · low 1 (2020)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FRN

172in 2025

2007high 312 (2013) · low 66 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FRN

7in 2025

2007high 102 (2009) · low 1 (2018)2026

Class I (37 since 2007) Class II/III not classified

Adverse event reports per year · FRN

52,792in 2025

2007high 888,020 (2022) · low 1,086 (2007)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	12	102	15	1,086
2008	8	89	24	8,261
2009	9	66	102	1,952
2010	3	93	37	6,133
2011	3	103	69	41,367
2012	4	217	42 (2)	15,482
2013	6	312	22 (3)	40,082
2014	6	172	4 (3)	94,180
2015	3	232	5	26,742
2016	3	301	7 (1)	16,560
2017	3	305	13	12,060
2018	3	267	1	16,591
2019	2	—	18 (1)	15,850
2020	1	—	16 (5)	94,186
2021	2	—	3 (2)	199,342
2022	6	268	2	888,020
2023	7	265	16 (10)	165,838
2024	5	103	9 (4)	57,730
2025	8	172	7 (4)	52,792
2026	2	—	11 (2)	—

What is it indicated for?

The Power Infuser® Model M100B-3A is intended for continuous or intermittent administration of therapeutic and clinically appropriate intravenous fluids, blood and packed red blood cells through clinically acceptable access points. The device is intended for use by medical, paramedical and EMT personnel in the field and in pre-hospital and hospital environments. When used with the Crystalloid/Colloid Cartridge the device is intended to deliver…

Read the full statement (119 words)

The Power Infuser® Model M100B-3A is intended for continuous or intermittent

administration of therapeutic and clinically appropriate intravenous fluids, blood and packed

red blood cells through clinically acceptable access points.

The device is intended for use by medical, paramedical and EMT personnel in the field and

in pre-hospital and hospital environments.

When used with the Crystalloid/Colloid Cartridge the device is intended to deliver

crystalloid and colloid resuscitative fluids. It is not intended to support the infusion of blood

or blood products.

When used with the Blood Cartridge the device is intended to deliver crystalloid and

colloid resuscitative fluids, whole blood and packed red blood.

The device is not intended to support the delivery of any pharmaceutical or other

medications.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K090736 · printed Nov 6, 2026

Cite this page

510(k) Report. “K090736: Power Infuser, Model M100B-3A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090736

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Record history

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