510(k) · Cleared

Cleared

Ventnet; Central Monitoring Station

K963633510(k) TraditionalCleared Dec 16, 199696-day reviewClass II21 CFR 868.5895

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

Puritan Bennett Corp. · MOD Accessory To Continuous Ventilator (Respirator)

Cleared on Dec 16, 1996 as substantially equivalent to K913038 (Spacelabs, Inc., 1991) and 1 other predicate after a 96-day review. Its family tree reaches back 1 generation to 1990. 1 later device descends from it.

Decided: Dec 16, 1996
Review: 96 days
Class: Class II
Product code: MOD
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K903702 (1990). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK903702 Model 90421 Flexport InterfaceSpacelabs, Inc. · 1990 · Recalled
This deviceK963633 Ventnet; Central Monitoring StationPuritan Bennett Corp. · 1996
Descendant · cites it directly · 0 of its ownK052751 Ventlink SystemMediserve Information Systems, Inc. · 2005

Most influential descendants

Showing 1 of 1 · See all

K052751Ventlink SystemMediserve Information Systems, Inc. · 2005 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K903702	Model 90421 Flexport Interface	Spacelabs, Inc.	1990	1
0 (this device)	K963633	Ventnet; Central Monitoring Station	Puritan Bennett Corp.	1996	—
+1	K052751	Ventlink System	Mediserve Information Systems, Inc.	2005	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1991	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0

FIG. 1 — Lineage of K963633, 1990–2005Source: 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 MOD? 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 MOD device

#1 K261360 EasyCare Tx 2score 14.6 · 10 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
*	K913038	Spacelab Model 90845 PCMS Multidisclosure Station Summary page 1 …rs and Receivers Classification Name: Transmitters and Receivers, Physiological Signal, Radiofrequency Substantially Equivalent to: Spacelabs PCMS Monitor, Model 90845 (K913038) Spacelabs Flexport Interface, Model 90436-01 (K903702) s ,1 SUMMARY OF VENTNET INTENDED USE 9A. PURPOSE AND FUNCTION OF DEV…	Spacelabs, Inc.	1991	—
*	K903702	Model 90421 Flexport Interface Summary page 1 …eceivers, Physiological Signal, Radiofrequency Substantially Equivalent to: Spacelabs PCMS Monitor, Model 90845 (K913038) Spacelabs Flexport Interface, Model 90436-01 (K903702) s ,1 SUMMARY OF VENTNET INTENDED USE 9A. PURPOSE AND FUNCTION OF DEVICE The VentNet system consists of a PC based Central M…	Spacelabs, Inc.	1990	1
†	K942147	Pacific Communications Model 1100	Accucore, Inc.	1995	—
†	K951370	Zymed Telemetry System; Model T8010	Zymed Medical Instrumentation	1995	—
†	K935846	Model Acuity Central Station	Protocol Systems, Inc.	1994	—
†	K942211	VMAX229 Series Pulmonary/Metabolic Systems	Sensor Medics Corp.	1994	—

Also cleared against K913038: 1 other device →

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
K052751	Ventlink System	Mediserve Information Systems, Inc.	2005	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?

1 of the 2 ancestors has a recall of any class.
Of its descendants, K052751 (Mediserve Information Systems, Inc., 2005) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K913038.

How does its category compare?

All MOD devices

MOD Accessory To Continuous Ventilator (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MOD

3so far in 2026, the most since 2007

2007high 3 (2026) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MOD

125in 2026

2007high 125 (2026)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MOD

1so far in 2026, the most since 2007

2007high 1 (2026) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MOD

1in 2022

2007high 6 (2019) · low 0 (2007)2025

MAUDE reports naming product code MOD, 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	0	—	0	0
2008	0	—	0	2
2009	1	—	0	0
2010	0	—	0	0
2011	0	—	0	0
2012	0	—	0	0
2013	0	—	0	0
2014	0	—	0	0
2015	0	—	0	3
2016	0	—	0	1
2017	1	—	0	1
2018	0	—	0	0
2019	0	—	0	6
2020	0	—	0	2
2021	0	—	0	0
2022	0	—	0	1
2023	0	—	0	0
2024	0	—	0	0
2025	1	—	0	0
2026	3	125	1	—

What is it indicated for?

Read the full statement (126 words)

VentNet’s intended use is to supplement the operation of dispersed or remotely located mechanical ventilators. VentNet allows the remote monitoring of multiple ventilators from a central station. VentNet displays ventilator settings, ventilator alarm status and physiological patient information as communicated from the monitored mechanical ventilator. VentNet also includes an optional feature which causes automatic notification, via paging system to defined users of certain ventilator alarms. VentNet is not intended to replace on-hand competent medical staff in monitoring for, or responding to ventilator alarms but is intended to support that staff by notifying other respiratory care staff or ventilator specialists in the event of certain alarm conditions.

VentNet’s secondary intended use is the automation of some of the record keeping and reporting functions performed during mechanical ventilation.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K963633 · printed Nov 5, 2026

Cite this page

510(k) Report. “K963633: Ventnet; Central Monitoring Station.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K963633

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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