510(k) · Cleared

Cleared

Millennium CRT Infusion Pump and Millennium CRT Infusion Pump Administration Sets

K972678510(k) TraditionalCleared Oct 7, 199783-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

Cleared on Oct 7, 1997 as substantially equivalent to K915522 (Baxter Healthcare Corp, 1992) and 11 other predicates after an 83-day review. Its family tree reaches back 1 generation to 1982. 6 of the 29 devices in its family, counting itself, have a Class I recall. 16 later devices descend from it.

Decided: Oct 7, 1997
Review: 83 days
Class: Class II
Product code: FRN
Recalls: None
Predicates: 12

Its longest line of descent runs back 1 generation to K820133 (1982). 12 ancestors in all. 16 later devices descend from it, 1 citing it directly. 6 of the 29 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 1 generation backK820133 Mcgaw Fat Emulsion SetAmerican Mcgaw · 1982
This deviceK972678 Millennium CRT Infusion Pump and Millennium CRT Infusion Pump…Mcgaw, Inc. · 1997
Descendant · cites it directly · 15 of its ownK062700 Infusomat Space Volumetric Infusion Pump SystemB.Braun Medical, Inc. · 2006 · Recalled (Class I)
Descendant · 2 generations on · 6 of its ownK140838 IV Administration Set with Hand PumpB.Braun Medical, Inc. · 2014
Descendant · 2 generations on · 4 of its ownK083689 Infusomat Space Volumetric Infusion Pump SystemB.Braun Medical, Inc. · 2009 · Recalled (Class I)
Descendant · 3 generations on · 3 of its ownK170595 IV Administration SetsB.Braun Medical, Inc. · 2017 · Recalled
Descendant · 2 generations on · 2 of its ownK121613 Agilia Infusion SystemFresenius Kabi AG · 2013 · Recalled (Class I)

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

2006high 3 (2020) · low 0 (2007)2026

Class I recalls in this family

K062700 Infusomat Space Volumetric Infusion Pump Systemcites it directly · 2006
K142036 Infusomat Space Volumetric Infusion Pump…2 generations on · 2014
K191910 SpaceStation MRI2 generations on · 2020
K121613 Agilia Infusion System2 generations on · 2013

Most influential descendants

Showing 5 of 16 · See all

K062700Infusomat Space Volumetric Infusion Pump SystemB.Braun Medical, Inc. · 2006 · cites it directly15descendants
K140838IV Administration Set with Hand PumpB.Braun Medical, Inc. · 2014 · 2 generations on6descendants
K083689Infusomat Space Volumetric Infusion Pump SystemB.Braun Medical, Inc. · 2009 · 2 generations on4descendants
K170595IV Administration SetsB.Braun Medical, Inc. · 2017 · 3 generations on3descendants
K121613Agilia Infusion SystemFresenius Kabi AG · 2013 · 2 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K820133	Mcgaw Fat Emulsion Set	American Mcgaw	1982	—
0 (this device)	K972678	Millennium CRT Infusion Pump and Millennium CRT Infusion Pump Administration…	Mcgaw, Inc.	1997	—
+1	K062700	Infusomat Space Volumetric Infusion Pump System	B.Braun Medical, Inc.	2006	Class I
+2	K140838	IV Administration Set with Hand Pump	B.Braun Medical, Inc.	2014	—
+2	K083689	Infusomat Space Volumetric Infusion Pump System	B.Braun Medical, Inc.	2009	Class I
+3	K170595	IV Administration Sets	B.Braun Medical, Inc.	2017	19
+2	K121613	Agilia Infusion System	Fresenius Kabi AG	2013	Class I

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1984	2	0
1986	1	0
1989	1	0
1990	1	0
1991	1	0
1992	2	0
1993	1	0
1994	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	1
2009	1	1
2013	1	1
2014	2	1
2015	1	1
2016	1	0
2017	1	0
2020	3	1
2021	1	0
2022	3	0
2025	1	0

FIG. 1 — Lineage of K972678, 1982–2025Source: 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.

6 devices in this family have a Class I recall. 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

Get a 510(k) Report

What was it cleared against? (13)

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
*	K915522	Flo-Gard (R) 6201 Summary page 2 …lornia §2623-9781 Telephone: 714.660.2000 Fax: 714.660.2700 $10(l) Summary The Flo-Gard® 6201 Volumetric Infusion Pump is marketed by Baxter under their cleared 510(k) K915522. The Flo-Gard® 6201 was introduced by Baxter as an upgrade to their Flo-Gard® 6200 Volumetric Infusion Pump. The following 510(k)…	Baxter Healthcare Corp	1992	6
*	K941244	Safeline System Turn Lock Cannula Summary page 2 …any Baxter cleared 610(k)s, including K924721 and K921703. The McGaw standard gravity and pump I.V. administration sets are marketed by McGaw under cleared McGaw 510(k)s K941244, K931377, K922637, K921860, K913661, K904518, K896292, K860157, K840248, K840212 and K820133. Description of the Subject Device…	Mcgaw, Inc.	1994	—
*	K931377	Safeline System IV Administration Sets & Component Summary page 2 …r cleared 610(k)s, including K924721 and K921703. The McGaw standard gravity and pump I.V. administration sets are marketed by McGaw under cleared McGaw 510(k)s K941244, K931377, K922637, K921860, K913661, K904518, K896292, K860157, K840248, K840212 and K820133. Description of the Subject Device The subj…	Mcgaw, Inc.	1994	16
*	K922637	Horizon Pump Y-Type Blood Set Summary page 2 …610(k)s, including K924721 and K921703. The McGaw standard gravity and pump I.V. administration sets are marketed by McGaw under cleared McGaw 510(k)s K941244, K931377, K922637, K921860, K913661, K904518, K896292, K860157, K840248, K840212 and K820133. Description of the Subject Device The subject devic…	Mcgaw, Inc.	1993	11
*	K921860	Modification to IV Spike Summary page 2 …including K924721 and K921703. The McGaw standard gravity and pump I.V. administration sets are marketed by McGaw under cleared McGaw 510(k)s K941244, K931377, K922637, K921860, K913661, K904518, K896292, K860157, K840248, K840212 and K820133. Description of the Subject Device The subject devices includ…	Mcgaw, Inc.	1992	6
*	K913661	Modified Volumetric Infusion Pump Summary page 2 …g K924721 and K921703. The McGaw standard gravity and pump I.V. administration sets are marketed by McGaw under cleared McGaw 510(k)s K941244, K931377, K922637, K921860, K913661, K904518, K896292, K860157, K840248, K840212 and K820133. Description of the Subject Device The subject devices include an elec…	Mcgaw, Inc.	1991	19
*	K904518	Volumetric Infusion Pump Summary page 2 …and K921703. The McGaw standard gravity and pump I.V. administration sets are marketed by McGaw under cleared McGaw 510(k)s K941244, K931377, K922637, K921860, K913661, K904518, K896292, K860157, K840248, K840212 and K820133. Description of the Subject Device The subject devices include an electrical, e…	Kendall Mcgaw Laboratories, Inc.	1990	37
*	K896292	1.2 Micron Filter with IV Set Summary page 2 …703. The McGaw standard gravity and pump I.V. administration sets are marketed by McGaw under cleared McGaw 510(k)s K941244, K931377, K922637, K921860, K913661, K904518, K896292, K860157, K840248, K840212 and K820133. Description of the Subject Device The subject devices include an electrical, external,…	Kendall Mcgaw Laboratories, Inc.	1989	—
*	K860157	Nitroglycerin Intravascular Administration Set Summary page 2 …McGaw standard gravity and pump I.V. administration sets are marketed by McGaw under cleared McGaw 510(k)s K941244, K931377, K922637, K921860, K913661, K904518, K896292, K860157, K840248, K840212 and K820133. Description of the Subject Device The subject devices include an electrical, external, linear pe…	Quest Medical, Inc.	1986	—
*	K840248	IV-Filter Summary page 2 …ndard gravity and pump I.V. administration sets are marketed by McGaw under cleared McGaw 510(k)s K941244, K931377, K922637, K921860, K913661, K904518, K896292, K860157, K840248, K840212 and K820133. Description of the Subject Device The subject devices include an electrical, external, linear peristaltic…	Tri-Med, Inc.	1984	—
*	K840212	Concentrated Platelet Admin. Set Summary page 2 …vity and pump I.V. administration sets are marketed by McGaw under cleared McGaw 510(k)s K941244, K931377, K922637, K921860, K913661, K904518, K896292, K860157, K840248, K840212 and K820133. Description of the Subject Device The subject devices include an electrical, external, linear peristaltic, volumet…	American Mcgaw	1984	8
*	K820133	Mcgaw Fat Emulsion Set Summary page 2 …p I.V. administration sets are marketed by McGaw under cleared McGaw 510(k)s K941244, K931377, K922637, K921860, K913661, K904518, K896292, K860157, K840248, K840212 and K820133. Description of the Subject Device The subject devices include an electrical, external, linear peristaltic, volumetric infusion…	American Mcgaw	1982	—
*	—	Standard Baxter solution administration sets intended for use with the Flo-Gard 6201 Pump Named without a submission number			—

Also cleared against K915522: 4 other devices →

What descends from it? (16)

See all 16

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

Number	Device	Applicant	Decided	Descendants
K062700	Infusomat Space Volumetric Infusion Pump System Class I	B.Braun Medical, Inc.	2006	15

Has anything in its family been recalled? (6 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K062700Infusomat Space Volumetric Infusion Pump SystemB.Braun Medical, Inc. · 2006 · Cites it directly · ◆ in the 2006 descendants bar of FIG. 11 Class I recall
K142036Infusomat Space Volumetric Infusion Pump Administration SetsB.Braun Medical, Inc. · 2014 · 2 generations on · ◆ in the 2014 descendants bar of FIG. 12 Class I recalls
K191910SpaceStation MRIB. Braun Melsugen AG · 2020 · 2 generations on · ◆ in the 2020 descendants bar of FIG. 13 Class I recalls
K121613Agilia Infusion SystemFresenius Kabi AG · 2013 · 2 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
K083689Infusomat Space Volumetric Infusion Pump SystemB.Braun Medical, Inc. · 2009 · 2 generations on · ◆ in the 2009 descendants bar of FIG. 11 Class I recall
K142596Infusomat Space Volumetric Infusion PumpB.Braun Medical, Inc. · 2015 · 3 generations on · ◆ in the 2015 descendants bar of FIG. 12 Class I recalls

Nearest 5 of 6; all are on the web page.

What does this lineage say?

7 of the 12 ancestors have a recall of any class.
Of its descendants, K062700 (B.Braun Medical, Inc., 2006) has gone furthest, with 15 descendants of its own.
4 other devices also cite its predicate K915522.

How does its category compare?

All FRN devices

FRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years.

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 Millennium CRT™ Infusion Pump and Millennium CRT™ Infusion Pump Administration Sets create an infusion system intended for parenteral and enteral administration. This includes, but is not limited to standard L.V. fluids (large volume parenterals and small volume parenterals), blood, blood components, nitroglycerin, Total Parenteral Nutrition (TPN), lipids, enteral fluids, 1.V. drugs such as paclitaxel and other chemotherapeutic agents, and epidural…

Read the full statement (254 words)

The Millennium CRT™ Infusion Pump Administration Sets can also be used as stand-alone devices without the Millennium CRT™ Infusion Pump. When used without the Millennium CRT™ Infusion Pump, the Millennium CRT™ Infusion Pump Administration Sets are also intended for parenteral and enteral administration. However, administration of these fluids is accomplished through gravity infusion. When used for gravity infusion, these sets may be used for administration of standard LV. fluids (large volume parenterals and small volume parenterals), blood, blood components, lipids, nitroglycerin, TPN, 1.V. drugs mcludmg paciltaxel and other chemotherapeutic agents, and -enteral fluids.

The Millennium CRT™ pump and associated administration sets are intended for, but are not limited to use in the hospital, home care and/or nursing home (extended care) settings. The Millennium CRT™ Infusion Pump is intended for use by trained healthcare providers in accordance with the instructions provided in the Operation Manual. All data entry and validation of the Millennium CRT™ Infusion Pump is performed by the trained healthcare provider per a physician’s order.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K972678 · printed Nov 6, 2026

Cite this page

510(k) Report. “K972678: Millennium CRT Infusion Pump and Millennium CRT Infusion Pump Administration Sets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972678

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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