510(k) · Cleared

Cleared

Repeater Pump II Tube Sets

K062909510(k) TraditionalCleared Mar 9, 2007163-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

Baxa Corp. · FPA Set, Administration, Intravascular

Cleared on Mar 9, 2007 as substantially equivalent to K872743 (Baxa Corp., Sub. of Cook Group, Inc., 1987) after a 163-day review. Its family tree reaches back 1 generation to 1987. 1 later device descends from it.

Decided: Mar 9, 2007
Review: 163 days
Class: Class II
Product code: FPA
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K872743 (1987). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK872743 Baxa Tubing Sets (for Pharmacy Pump)Baxa Corp., Sub. of Cook Group, Inc. · 1987
This deviceK062909 Repeater Pump II Tube SetsBaxa Corp. · 2007
Descendant · cites it directly · 0 of its ownK200893 ProntoPump Sterile Tube SetIpax, Inc. · 2021

Most influential descendants

Showing 1 of 1 · See all

K200893ProntoPump Sterile Tube SetIpax, Inc. · 2021 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K872743	Baxa Tubing Sets (for Pharmacy Pump)	Baxa Corp., Sub. of Cook Group, Inc.	1987	—
0 (this device)	K062909	Repeater Pump II Tube Sets	Baxa Corp.	2007	—
+1	K200893	ProntoPump Sterile Tube Set	Ipax, Inc.	2021	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2021	1	0

FIG. 1 — Lineage of K062909, 1987–2021Source: 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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K872743	Baxa Tubing Sets (for Pharmacy Pump) Summary page 1 …Code LHI (b) Classification. Class II Manufacturer: Baxa Corporation 510(k) Number: K872743 Product Description: The Repeater Pump IItube set provides the fluid pathway, pump cavity, v…	Baxa Corp., Sub. of Cook Group, Inc.	1987	—

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K200893	ProntoPump Sterile Tube Set	Ipax, Inc.	2021	0

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?

Its one ancestor has no recall.
Of its descendants, K200893 (Ipax, Inc., 2021) has gone furthest, with 0 descendants of its own.

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 Repeater Pump IItube set tube sets are fluid transfer tube sets used in conjunction with the Repeater Pump IIpharmacy pump in hospital and compounding pharmacies to provide a pathway through which fluid is transferred from one source container into another suitable container.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K062909 · printed Nov 6, 2026

Cite this page

510(k) Report. “K062909: Repeater Pump II Tube Sets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062909

Report an extraction error

Are you the manufacturer?

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