510(k) · Cleared

Recalled · Class II · 2011

Z-800 Volumetric Infusion Pump

K071545510(k) TraditionalCleared Oct 31, 2007147-day reviewClass II21 CFR 880.5725Recalls 1

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

Cleared on Oct 31, 2007 after a 147-day review. The FDA summary names no predicate by number. 2 of the 3 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it. It has been recalled once.

Decided: Oct 31, 2007
Review: 147 days
Class: Class II
Product code: FRN
Recalls: 1
Predicates: 0

2 later devices descend from it, 1 citing it directly. 2 of the 3 devices in this family, counting this one, have a Class I recall.

This deviceK071545 Z-800 Volumetric Infusion PumpZyno Medical, LLC · 2007
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)

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 2 of 2 · 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

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K071545	Z-800 Volumetric Infusion Pump	Zyno Medical, LLC	2007	—
+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

Descendants by year cleared

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

FIG. 1 — Lineage of K071545, 2007–2013Source: 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 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?

The FDA summary names no predicate by number.

What descends from it? (2)

1 later device cites 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

Has anything in its family been recalled? (2 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jun 13, 2011	Class II	Z-1024-2013	Process design	Update Instruction For Use for Preventative Maintenance (PM) Schedule and addition of Odometer software to monitor accumulative fluid volume infused by the pump

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. 2007, this device’s year, is highlighted.

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)	—

What is it indicated for?

The Z-800 Infusion pump is intended to provide accurate delivery of

parenteral fluids to a human patient under the direction or supervision of physician or

other certified health care professional.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K071545 · printed Nov 4, 2026

Cite this page

510(k) Report. “K071545: Z-800 Volumetric Infusion Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071545

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