510(k) · Cleared
ClearedPower Infuser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ZOLL Medical Corporation · FRN Pump, Infusion
Cleared on Jul 18, 2018 as substantially equivalent to K090736 (ZOLL Medical Corporation, 2009) after a 316-day review. Its family tree reaches back 2 generations to 1982.
- Decided
- Jul 18, 2018
- Review
- 316 days
- Class
- Class II
- Product code
- FRN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K820159 (1982). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K820159 | Pressure Infuser | David Clark Company, Inc. | 1982 | — |
| −1 | K090736 | Power Infuser, Model M100B-3A | ZOLL Medical Corporation | 2009 | — |
| 0 (this device) | K172653 | Power Infuser | ZOLL Medical Corporation | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
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
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 | Decided |
|---|---|---|---|
| * | K090736 | Power Infuser, Model M100B-3ASummary page 4…Name: Infusion Pump Classification Name: Infusion Pump (21 CFR 880.5725) Product Code: FRN Predicate Device: Power Infuser, Model M100B-3A (K090736) Device Description: The ZOLL Power Infuser (reviewed and cleared with K090736) is a miniature battery-operated infusion pump de… | 2009 |
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.
What does this lineage say?
- The line of descent spans 36 years and passes through 2 companies; a new generation was cleared every 27.1 years on median.
- 1 of the 3 ancestors has a recall of any class.
How does its category compare?
All FRN devicesFRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · FRN
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRN
172in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRN
7in 2025
Class I (37 since 2007) Class II/III not classified
Adverse event reports per year · FRN
52,792in 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® 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…
Read the full statement (117 words)
The Power Infuser® 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/K172653 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172653: 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/K172653
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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