510(k) · Cleared

Recalled · 2011

Flo-Gard (R) 6301

K915523510(k) TraditionalCleared Feb 28, 199280-day reviewClass II21 CFR 880.5725Recalls 3

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

Baxter Healthcare Corp · FRN Pump, Infusion

Cleared on Feb 28, 1992 after an 80-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it. It has been recalled 3 times.

Decided: Feb 28, 1992
Review: 80 days
Class: Class II
Product code: FRN
Recalls: 3
Predicates: 0

2 later devices descend from it, 2 citing it directly.

This deviceK915523 Flo-Gard (R) 6301Baxter Healthcare Corp · 1992
Descendant · cites it directly · 0 of its ownK032789 Replacement Pump Head Door Assembly, P1, Model BX10468, Replacement…American I.V. Products, Inc. · 2003
Descendant · cites it directly · 0 of its ownK973640 TS2000 Medical Device MonitorTrincore Systems, Inc. · 1998

Most influential descendants

Showing 2 of 2 · See all

K032789Replacement Pump Head Door Assembly, P1, Model BX10468, Replacement Pump Head Door…American I.V. Products, Inc. · 2003 · cites it directly0descendants
K973640TS2000 Medical Device MonitorTrincore Systems, Inc. · 1998 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K915523	Flo-Gard (R) 6301	Baxter Healthcare Corp	1992	—
+1	K032789	Replacement Pump Head Door Assembly, P1, Model BX10468, Replacement Pump Head…	American I.V. Products, Inc.	2003	—
+1	K973640	TS2000 Medical Device Monitor	Trincore Systems, Inc.	1998	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
2003	1	0

FIG. 1 — Lineage of K915523, 1992–2003Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K032789	Replacement Pump Head Door Assembly, P1, Model BX10468, Replacement Pump Head Door…	American I.V. Products, Inc.	2003	0
K973640	TS2000 Medical Device Monitor	Trincore Systems, Inc.	1998	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Aug 26, 2011	Not classified	Z-0134-2012	Employee error	The Flo-Gard infusion Pump was released to the customer with OOS values for the Air Sensor Calibrations with the Air in Tubing test.
Jun 21, 2007	Not classified	Z-1112-2007	Other	Falsified Repair/Test and Inspection records: Pumps submitted for repair or service may not have been properly repaired or serviced before being returned to the customer.
Nov 27, 2006	Not classified	Z-0633-2007	Other	There is the potential for non-detection of, and no alarm for, upstream occlusion for Flo-Gard Volumetric Infusion Pumps, if an occlusion occurs above a flexible chamber such as a drip chamber, Buretrol or blood filter.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K032789 (American I.V. Products, Inc., 2003) 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.

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)	—

https://510kreport.com/device/K915523 · printed Nov 3, 2026

Cite this page

510(k) Report. “K915523: Flo-Gard (R) 6301.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K915523

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026