510(k) · Cleared
ClearedRemcore Remote Controlled Oxygen Regulator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Remcore, Inc. · CAN Regulator, Pressure, Gas Cylinder
Cleared on Oct 25, 2006 after a 266-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Oct 25, 2006
- Review
- 266 days
- Class
- Class I
- Product code
- CAN
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CAN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
How does its category compare?
All CAN devicesCAN Regulator, Pressure, Gas Cylinder: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CAN
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · CAN
Too few CAN 510(k)s in any year since 2007 to give a median.
Recalls per year · CAN
3in 2021
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · CAN
3in 2025
MAUDE reports naming product code CAN, 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 | 2 |
| 2008 | 0 | — | 0 | 8 |
| 2009 | 1 | — | 5 | 5 |
| 2010 | 0 | — | 0 | 7 |
| 2011 | 0 | — | 0 | 5 |
| 2012 | 0 | — | 1 (1) | 23 |
| 2013 | 0 | — | 0 | 6 |
| 2014 | 0 | — | 0 | 12 |
| 2015 | 0 | — | 1 | 12 |
| 2016 | 0 | — | 0 | 13 |
| 2017 | 1 | — | 0 | 11 |
| 2018 | 0 | — | 0 | 238 |
| 2019 | 0 | — | 0 | 20 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 3 | 6 |
| 2022 | 0 | — | 0 | 6 |
| 2023 | 0 | — | 0 | 19 |
| 2024 | 0 | — | 0 | 59 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Remcore Remote Control Oxygen Delivery system is an adjunct to the use of supplemental oxygen prescribed by a physician for a patient whose lung disease limits his or her ability to adequately supply the body with oxygen. The amount of supplemental oxygen needed to continuously provide the oxygen saturation prescribed will vary with different degrees of exertion. Current oxygen delivery systems do not allow a patient to alter the flow rate of oxygen…
Read the full statement (178 words)
The Remcore Remote Control Oxygen Delivery system is an adjunct to the use of supplemental oxygen prescribed by a physician for a patient whose lung disease limits his or her ability to adequately supply the body with oxygen. The amount of supplemental oxygen needed to continuously provide the oxygen saturation prescribed will vary with different degrees of exertion. Current oxygen delivery systems do not allow a patient to alter the flow rate of oxygen when the patient is not next to the oxygen source. The Remncore Remote Control Oxygen Delivery System allows a patient to change the flow rate, as prescribed by the physician, in accordance with the activity of the patient. For example, a patient might require 2 liters/minute of supplemental oxygen at rest, but 5 liters/minute to climb the stairs. The Remcore system will allow the patient sitting downstairs to remotely increase the oxygen flow rate to 5 liters/minute, regardless of where in the house the oxygen tank or concentrator is located, and after arriving upstairs to remotely return the oxygen flow rate to 2 liters/minute.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K060265 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060265: Remcore Remote Controlled Oxygen Regulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060265
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026