510(k) · Cleared
ClearedVentlink System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mediserve Information Systems, Inc. · MOD Accessory To Continuous Ventilator (Respirator)
Cleared on Dec 23, 2005 as substantially equivalent to K963633 (Puritan Bennett Corp., 1996) after an 84-day review. Its family tree reaches back 2 generations to 1990.
- Decided
- Dec 23, 2005
- Review
- 84 days
- Class
- Class II
- Product code
- MOD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K903702 (1990). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K903702 | Model 90421 Flexport Interface | Spacelabs, Inc. | 1990 | 1 |
| −1 | K963633 | Ventnet; Central Monitoring Station | Puritan Bennett Corp. | 1996 | — |
| 0 (this device) | K052751 | Ventlink System | Mediserve Information Systems, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K963633 | Ventnet; Central Monitoring StationSummary page 1…LEGALLY MARKETED PREDICATE DEVICE - as required by 807.92(a)(3) The VentLink device is substantially equivalent to the Ventnet system, K963633, submitted by Puritan Bennett Corporation, Tustin, CA. B. DEVICE DESCRIPTION - as required by 807.92(a)(4) The V… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 9.0 years on median.
- 1 of the 3 ancestors has a recall of any class.
How does its category compare?
All MOD devicesMOD 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
2026 to Oct 25, outlined.
Median 510(k) review, days · MOD
125in 2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MOD
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MOD
1in 2022
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?
The VentLink System is intended to be used in any clinical setting while interfaced to any specified or validated ventilator device. The VentLink system is intended to provide a secondary display of data received from an interfaced ventilator device to appropriately configured workstations and wireless laptop computers and to be made available to any interfaced hospital information system (HIS).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052751 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052751: Ventlink System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052751
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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