510(k) · Cleared

Cleared

Infusomat P

K003029510(k) TraditionalCleared Dec 4, 200067-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

B.Braun Medical, Inc. · FRN Pump, Infusion

Cleared on Dec 4, 2000 after a 67-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 4 devices in its family, counting itself, have a Class I recall. 3 later devices descend from it.

Decided: Dec 4, 2000
Review: 67 days
Class: Class II
Product code: FRN
Recalls: None
Predicates: 0

3 later devices descend from it, 2 citing it directly. 2 of the 4 devices in this family, counting this one, have a Class I recall.

This deviceK003029 Infusomat PB.Braun Medical, Inc. · 2000
Descendant · cites it directly · 1 of its ownK100705 Zyno Z-800 Infusion System Model Z-800Zyno Medical, LLC · 2010 · Recalled (Class I)
Descendant · 2 generations on · 0 of its ownK130690 Z-800 Infusion SystemZyno Medical, LLC · 2013 · Recalled (Class I)
Descendant · cites it directly · 0 of its ownK070529 Aff (Mark I) Volumetric Infusion PumpDefinitive Medical Technologies, Ltd. · 2007 · Recalled

Class I recalls in this family

K100705 Zyno Z-800 Infusion System Model Z-800cites it directly · 2010
K130690 Z-800 Infusion System2 generations on · 2013

Most influential descendants

Showing 3 of 3 · See all

K100705Zyno Z-800 Infusion System Model Z-800Zyno Medical, LLC · 2010 · cites it directly1descendant
K130690Z-800 Infusion SystemZyno Medical, LLC · 2013 · 2 generations on0descendants
K070529Aff (Mark I) Volumetric Infusion PumpDefinitive Medical Technologies, Ltd. · 2007 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K003029	Infusomat P	B.Braun Medical, Inc.	2000	—
+1	K100705	Zyno Z-800 Infusion System Model Z-800	Zyno Medical, LLC	2010	Class I
+2	K130690	Z-800 Infusion System	Zyno Medical, LLC	2013	Class I
+1	K070529	Aff (Mark I) Volumetric Infusion Pump	Definitive Medical Technologies, Ltd.	2007	5

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2010	1	1
2013	1	1

FIG. 1 — Lineage of K003029, 2000–2013Source: 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.

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 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?

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

What descends from it? (3)

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

Number	Device	Applicant	Decided	Descendants
K100705	Zyno Z-800 Infusion System Model Z-800 Class I	Zyno Medical, LLC	2010	1
K070529	Aff (Mark I) Volumetric Infusion Pump	Definitive Medical Technologies, Ltd.	2007	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.

K100705Zyno Z-800 Infusion System Model Z-800Zyno Medical, LLC · 2010 · Cites it directly · ◆ in the 2010 descendants bar of FIG. 15 Class I recalls
K130690Z-800 Infusion SystemZyno Medical, LLC · 2013 · 2 generations on · ◆ in the 2013 descendants bar of FIG. 15 Class I recalls

What does this lineage say?

Of its descendants, K100705 (Zyno Medical, LLC, 2010) has gone furthest, with 1 descendant 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/K003029 · printed Nov 6, 2026

Cite this page

510(k) Report. “K003029: Infusomat P.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003029

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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