510(k) · Cleared

Cleared

Bolus Accessory Set

K992072510(k) TraditionalCleared Sep 15, 199988-day reviewClass II21 CFR 880.5440

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

I-Flow Corp. · FPA Set, Administration, Intravascular

Cleared on Sep 15, 1999 as substantially equivalent to K984638 (I-Flow Corp., 1999) and 2 other predicates after an 88-day review. Its family tree reaches back 2 generations to 1989. 2 of the 25 devices in its family, counting itself, have a Class I recall. 21 later devices descend from it.

Decided: Sep 15, 1999
Review: 88 days
Class: Class II
Product code: FPA
Recalls: None
Predicates: 3

Its longest line of descent runs back 2 generations to K884505 (1989). 3 ancestors in all. 21 later devices descend from it, 2 citing it directly. 2 of the 25 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 2 generations backK884505 Basal/Bolus InfusorsBaxter Healthcare Corp · 1989 · Recalled
1 generation backK984638 Paragon Bolus Accessory SetI-Flow Corp. · 1999
This deviceK992072 Bolus Accessory SetI-Flow Corp. · 1999
Descendant · cites it directly · 19 of its ownK020862 I-Flow Elastomeric PumpI-Flow Corp. · 2002 · Recalled
Descendant · 2 generations on · 17 of its ownK023098 Accufuser, Accufuser Plus, Standard Procedure Kit, Accufuser…Mckinley Infuser · 2002
Descendant · 3 generations on · 15 of its ownK033039 Modification to: Accufuser, Accufuser Plus, Standard Procedure KitsMckinley, Inc. · 2003
Descendant · 3 generations on · 8 of its ownK032642 Beeline SystemMckinley, Inc. · 2003
Descendant · 4 generations on · 7 of its ownK042228 Beeline Motiv, Propolis, PcaMckinley, Inc. · 2004

Showing 5 of 21 descendants. See all descendants

Descendants cleared per year

2002high 4 (2002) · low 0 (2007)2026

Class I recalls in this family

K023318 I-Flow Elastomeric Pump with Bolus2 generations on · 2002
K081905 Accuflow and Accuflux Elastomeric Infusion Pump6 generations on · 2008

Most influential descendants

Showing 5 of 21 · See all

K020862I-Flow Elastomeric PumpI-Flow Corp. · 2002 · cites it directly19descendants
K023098Accufuser, Accufuser Plus, Standard Procedure Kit, Accufuser Infusion KitMckinley Infuser · 2002 · 2 generations on17descendants
K033039Modification to: Accufuser, Accufuser Plus, Standard Procedure KitsMckinley, Inc. · 2003 · 3 generations on15descendants
K032642Beeline SystemMckinley, Inc. · 2003 · 3 generations on8descendants
K042228Beeline Motiv, Propolis, PcaMckinley, Inc. · 2004 · 4 generations on7descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K884505	Basal/Bolus Infusors	Baxter Healthcare Corp	1989	2
−1	K984638	Paragon Bolus Accessory Set	I-Flow Corp.	1999	—
0 (this device)	K992072	Bolus Accessory Set	I-Flow Corp.	1999	—
+1	K020862	I-Flow Elastomeric Pump	I-Flow Corp.	2002	1
+2	K023098	Accufuser, Accufuser Plus, Standard Procedure Kit, Accufuser Infusion Kit	Mckinley Infuser	2002	—
+3	K033039	Modification to: Accufuser, Accufuser Plus, Standard Procedure Kits	Mckinley, Inc.	2003	—
+3	K032642	Beeline System	Mckinley, Inc.	2003	—
+4	K042228	Beeline Motiv, Propolis, Pca	Mckinley, Inc.	2004	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	4	1
2003	2	0
2004	2	0
2005	4	0
2006	3	0
2008	1	1
2009	1	0
2016	1	0
2024	2	0
2026	1	0

FIG. 1 — Lineage of K992072, 1989–2026Source: 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.

2 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 FPA device

#1 K243841 Sparta Infusion Set for Insulinscore 13.4 · 3 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? (3)

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
*	K984638	Paragon Bolus Accessory Set Summary page 2 …l and Personal Use Device T T G 'S NO b WN Statement of Equivalence 1.2.1 The Bolus Accessory is substantially equivalent to the I-Flow Paragon ‘Bolus Accessory Set (K984638), the Patient Control Module (K884505) -marketed by Baxter Healthcare Corporation and the I-Flow Bolus Dispenser (K935811). PHYS…	I-Flow Corp.	1999	—
*	K884505	Basal/Bolus Infusors Summary page 2 …b WN Statement of Equivalence 1.2.1 The Bolus Accessory is substantially equivalent to the I-Flow Paragon ‘Bolus Accessory Set (K984638), the Patient Control Module (K884505) -marketed by Baxter Healthcare Corporation and the I-Flow Bolus Dispenser (K935811). PHYSICAL SPECIFICATIONS AND DESCRIPTIONS…	Baxter Healthcare Corp	1989	2
*	K935811	Bolus Dispenser Summary page 2 …ent to the I-Flow Paragon ‘Bolus Accessory Set (K984638), the Patient Control Module (K884505) -marketed by Baxter Healthcare Corporation and the I-Flow Bolus Dispenser (K935811). PHYSICAL SPECIFICATIONS AND DESCRIPTIONS 2.1 2.2 2.3 2.4 Description of the Bolus Accessory 2.1.1 The Bolus Accessory m…	I-Flow Corp.	1995	—

Also cleared against K984638: 1 other device →

What descends from it? (21)

See all 21

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

Number	Device	Applicant	Decided	Descendants
K020862	I-Flow Elastomeric Pump	I-Flow Corp.	2002	19
K020660	Homepump, Eclipse, C-Series, Painbuster, C-Bloc, on-Q, Easypump, One Step Kvo	I-Flow Corp.	2002	0

Has anything in its family been recalled? (2 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.

K023318I-Flow Elastomeric Pump with BolusI-Flow Corp. · 2002 · 2 generations on · ◆ in the 2002 descendants bar of FIG. 11 Class I recall
K081905Accuflow and Accuflux Elastomeric Infusion PumpWestmed, Inc. · 2008 · 6 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 9.6 years on median.
1 of the 3 ancestors has a recall of any class.
Of its descendants, K020862 (I-Flow Corp., 2002) has gone furthest, with 19 descendants of its own.
1 other device also cites its predicate K984638.

How does its category compare?

All FPA devices

FPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FPA

11in 2025

2007high 23 (2010) · low 4 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FPA

225in 2025

2007high 340 (2023) · low 75 (2007)2026

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

Recalls per year · FPA

98in 2025

2007high 166 (2009) · low 1 (2021)2026

Class I (17 since 2007) Class II/III not classified

Adverse event reports per year · FPA

34,506in 2025

2007high 47,210 (2024) · low 1,499 (2007)2025

MAUDE reports naming product code FPA, 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	16	75	17	1,499
2008	18	89	15	1,941
2009	10	166	166	2,512
2010	23	120	58	2,537
2011	12	87	28	4,407
2012	21	96	16 (4)	4,930
2013	13	90	64	4,651
2014	22	89	24	4,695
2015	17	123	6	6,625
2016	12	195	10	8,470
2017	17	240	13	6,462
2018	4	177	4	6,574
2019	7	161	13	11,227
2020	10	327	107	9,563
2021	13	186	1	10,414
2022	14	213	9 (5)	13,393
2023	14	340	12 (4)	10,916
2024	7	244	13 (1)	47,210
2025	11	225	98 (1)	34,506
2026	5	266	10 (2)	—

What is it indicated for?

The Bolus Accessory Set, in combination with a positive pressure, continuous flow infusion pump, is intended to deliver fixed boluses of medication upon demand by the patient or healthcare provider. Routes of administration include intravenous, epidural, intramuscular, subcutaneous, intra-operative and percutaneous.

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/K992072 · printed Nov 6, 2026

Cite this page

510(k) Report. “K992072: Bolus Accessory Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992072

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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