510(k) · Cleared
ClearedCorVision® (91-205-Z0014)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
CorVent® Medical, Inc. · MOD Accessory To Continuous Ventilator (Respirator)
Cleared on May 12, 2026 as substantially equivalent to K161411 (Respironics, Inc., 2017) after a 124-day review. Its family tree reaches back 2 generations to 2001.
- Decided
- May 12, 2026
- Review
- 124 days
- Class
- Class II
- Product code
- MOD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K011861 (2001). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K161411 | Care Cycle Connect ApplicationSummary page 5…ntilator (Respirator) Device Regulatory Class Class II Predicate Device Name Care Cycle Connect Application – K161411 Predicate Regulation Number 868.5895 Predicate Regulation Name Continuous Ven… | 2017 |
| † | K241135 | RESPOND (R) Ventilator | 2024 |
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 25 years and passes through 3 companies; a new generation was cleared every 15.3 years on median.
- None of the 2 ancestors has a recall.
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. 2026, this device’s year, is highlighted.
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?
CorVision® is only compatible with and intended for use exclusively with the CorVent® RESPOND® Ventilator (K241135) by qualified, trained personnel under the direction of a licensed clinician. This application wirelessly interfaces with the RESPOND® Ventilator to receive data and provides a supplemental display of ventilator parameters, settings, measurements, status, waveforms, and event log information. The application operates in read-only mode and…
Read the full statement (132 words)
CorVision® is only compatible with and intended for use exclusively with the CorVent® RESPOND® Ventilator (K241135) by qualified, trained personnel under the direction of a licensed clinician. This application wirelessly interfaces with the RESPOND® Ventilator to receive data and provides a supplemental display of ventilator parameters, settings, measurements, status, waveforms, and event log information. The application operates in read-only mode and has no ventilator settings or alarm control functions. The RESPOND® Ventilator is intended for pediatrics through adult patients weighing at least 38 kg (84 lbs).
CorVision® is intended for use in hospital and institutional environments, including intra-hospital transport, long-term acute care, skilled nursing facilities, long-term care, and subacute care facilities (same as the RESPOND® Ventilator). CorVision® is intended to supplement and not replace any part of the current ventilator monitoring procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260051 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260051: CorVision® (91-205-Z0014).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260051
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026