510(k) · Cleared

Recalled · Class I · 2025

Zyno Z-800 Infusion System Model Z-800

K100705510(k) AbbreviatedCleared Jul 8, 2010118-day reviewClass II21 CFR 880.5725Recalls 8 (5 Class I)

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

Cleared on Jul 8, 2010 as substantially equivalent to K071545 (Zyno Medical, LLC, 2007) and 3 other predicates after a 118-day review. Its family tree reaches back 1 generation to 1995. 3 of the 6 devices in its family, counting itself, have a Class I recall. 1 later device descends from it. It has been recalled 8 times, including 5 Class I recalls.

Decided: Jul 8, 2010
Review: 118 days
Class: Class II
Product code: FRN
Recalls: 8 (5 Class I)
Predicates: 4

Its longest line of descent runs back 1 generation to K950766 (1995). 4 ancestors in all. 1 later device descends from it, 1 citing it directly. 3 of the 6 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 1 generation backK950766 Sigma 8000 and Sigma 8002Sigma Intl. General Medical Apparatus, Inc. · 1995
This deviceK100705 Zyno Z-800 Infusion System Model Z-800Zyno Medical, LLC · 2010
Descendant · cites it directly · 0 of its ownK130690 Z-800 Infusion SystemZyno Medical, LLC · 2013 · Recalled (Class I)

Class I recalls in this family

K991501 Acclaim Infusion Pumpdirect predicate · 1999
K130690 Z-800 Infusion Systemcites it directly · 2013

Most influential descendants

Showing 1 of 1 · See all

K130690Z-800 Infusion SystemZyno Medical, LLC · 2013 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K950766	Sigma 8000 and Sigma 8002	Sigma Intl. General Medical Apparatus, Inc.	1995	—
0 (this device)	K100705	Zyno Z-800 Infusion System Model Z-800	Zyno Medical, LLC	2010	—
+1	K130690	Z-800 Infusion System	Zyno Medical, LLC	2013	Class I

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1999	1	1
2000	1	0
2007	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	1	1

FIG. 1 — Lineage of K100705, 1995–2013Source: 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.

3 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

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What was it cleared against? (4)

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
*	K071545	Z-800 Volumetric Infusion Pump Summary page 1 …Common Name: Volumetric Infusion Pump Classification Name: Infusion Pump Product code: FRN 880.5725 Predicate Devices -Z-800 Infusion pumps (K07 1545) -B. Braun Vista basic (formerly known as Infusomnat P, K003029) -Sigma 8000 (K950766) -Abbott Acclaim Encor…	Zyno Medical, LLC	2007	1
*	K003029	Infusomat P Summary page 1 …on Pump Product code: FRN 880.5725 Predicate Devices -Z-800 Infusion pumps (K07 1545) -B. Braun Vista basic (formerly known as Infusomnat P, K003029) -Sigma 8000 (K950766) -Abbott Acclaim Encore (K99150 1) Intended Use The Z-800 Infusion system is i…	B.Braun Medical, Inc.	2000	—
*	K950766	Sigma 8000 and Sigma 8002 Summary page 1 …FRN 880.5725 Predicate Devices -Z-800 Infusion pumps (K07 1545) -B. Braun Vista basic (formerly known as Infusomnat P, K003029) -Sigma 8000 (K950766) -Abbott Acclaim Encore (K99150 1) Intended Use The Z-800 Infusion system is intended to provide intravenou…	Sigma Intl. General Medical Apparatus, Inc.	1995	—
*	K991501	Acclaim Infusion Pump Summary page 1 …-Z-800 Infusion pumps (K07 1545) -B. Braun Vista basic (formerly known as Infusomnat P, K003029) -Sigma 8000 (K950766) -Abbott Acclaim Encore (K99150 1) Intended Use The Z-800 Infusion system is intended to provide intravenous infusion of parenteral fluids, blood an…	Abbott Laboratories	1999	Class I

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
K130690	Z-800 Infusion System Class I	Zyno Medical, LLC	2013	0

Has anything in its family been recalled? (3 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
May 7, 2025	Class I	Z-1867-2025	Software design (manufacturing process)	Unreleased software versions were installed on distributed devices without verification or validation.
May 7, 2025	Class I	Z-1868-2025	Software design (manufacturing process)	Unreleased software versions were installed on distributed devices without verification or validation.
May 7, 2025	Class I	Z-1865-2025	Software design (manufacturing process)	Unreleased software versions were installed on distributed devices without verification or validation.
May 7, 2025	Class I	Z-1866-2025	Software design (manufacturing process)	Unreleased software versions were installed on distributed devices without verification or validation.
Oct 18, 2024	Class II	Z-0506-2025	Device Design	Potential for the battery to deplete over time from self-discharge and internal parasitic leakage current despite being continuously plugged into AC mains.
Sep 30, 2024	Class III	Z-0523-2025	Software design (manufacturing process)	For the Z-800WF pumps, the WiFi software was not compatible with the pump software that had been loaded in accordance with ongoing correction Z-1183-2024.
Sep 13, 2024	Class I	Z-0005-2025	Process change control	There is a defect in the air-in-line software algorithm.
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

The 5 latest of 8 recalls; the web page lists all.

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.

K991501Acclaim Infusion PumpAbbott Laboratories · 1999 · Direct predicate · ◆ in the 1999 ancestors bar of FIG. 11 Class I recall
K130690Z-800 Infusion SystemZyno Medical, LLC · 2013 · Cites it directly · ◆ in the 2013 descendants bar of FIG. 15 Class I recalls

What does this lineage say?

2 of the 4 ancestors have a recall of any class; 1 has a Class I recall.
Of its descendants, K130690 (Zyno Medical, LLC, 2013) has gone furthest, with 0 descendants 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. 2010, 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 system is intended to provide intravenous infusion of parenteral fluids, blood and blood products 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/K100705 · printed Nov 6, 2026

Cite this page

510(k) Report. “K100705: Zyno Z-800 Infusion System Model Z-800.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100705

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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