510(k) · Cleared

Cleared

Promepla Intravascular Administration Set and Extension Set

K071421510(k) TraditionalCleared Oct 4, 2007135-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

Promepla · FPA Set, Administration, Intravascular

Cleared on Oct 4, 2007 as substantially equivalent to K051499 (Medegen Medical Manufacturing Services, 2005) and 1 other predicate after a 135-day review. Its family tree reaches back 2 generations to 1995.

Decided: Oct 4, 2007
Review: 135 days
Class: Class II
Product code: FPA
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K942391 (1995). 4 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK942391 Braun ManifoldB.Braun Medical, Inc. · 1995
1 generation backK970255 Kipp Med I.V. ManifoldThe Kipp Group · 1997
This deviceK071421 Promepla Intravascular Administration Set and Extension SetPromepla · 2007

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K942391	Braun Manifold	B.Braun Medical, Inc.	1995	—
−1	K970255	Kipp Med I.V. Manifold	The Kipp Group	1997	—
0 (this device)	K071421	Promepla Intravascular Administration Set and Extension Set	Promepla	2007	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2005	1	0

FIG. 1 — Lineage of K071421, 1995–2007Source: 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 FPA? 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

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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
*	K051499	Intravascular Administration Set and Extension Set Summary page 1 …nistration Set Classification Number: 21 CFR 880.5440 Classification Name: Set, Administration, Intravascular Product Code: FPA Predicate Devices: K051499, Intravascular Administration Set and Extension Set, Medegen Medical Manufacturing Services…	Medegen Medical Manufacturing Services	2005	24
*	K970255	Kipp Med I.V. Manifold Summary page 1 …te Devices: K051499, Intravascular Administration Set and Extension Set, Medegen Medical Manufacturing Services K970255, KippMed I.V. Manifold, The Kipp Group Statement of Intended The Intravascular Administration Set and Extension Set is a devi…	The Kipp Group	1997	—

Also cleared against K051499: 4 other devices →

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 12 years and passes through 3 companies; a new generation was cleared every 10.5 years on median.
2 of the 4 ancestors have a recall of any class.
4 other devices also cite its predicate K051499.

How does its category compare?

All FPA devices

FPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

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 Intravascular Administration Set and Extension Set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the patient's artery or vein. The Administration Set is also intended for use with a peristaltic pump for IV purposes only.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K071421 · printed Nov 6, 2026

Cite this page

510(k) Report. “K071421: Promepla Intravascular Administration Set and Extension Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071421

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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