510(k) · Cleared
ClearedCarecube Negative Pressure Isolation Chamber
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carecubes, Inc. · LGM Chamber, Patient Isolation
Cleared on Jan 3, 2024 as substantially equivalent to K052798 (Isovac Products, LLC, 2006) after a 247-day review. Its family tree reaches back 2 generations to 1979.
- Decided
- Jan 3, 2024
- Review
- 247 days
- Class
- Class II
- Product code
- LGM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K790657 (1979). 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 LGM? 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? (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 |
|---|---|---|---|
| * | K052798 | Capsuls, Models 2003-PUR8C, 2004-PVC8CSummary page 6…te Device: Predicate Device Name 510(k) Company Name CAPSULS™ Patient Isolation Unit K052798 ISOVAC Products, LLC Reference Device ORCA™ Operational Rescue K163223… | 2006 |
| † | K163223 | ORCA (tm) - Operational Rescue Containment Apparatus | 2017 |
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 45 years and passes through 3 companies; a new generation was cleared every 26.9 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K052798.
How does its category compare?
All LGM devicesLGM Chamber, Patient Isolation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · LGM
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LGM
Too few LGM 510(k)s in any year since 2007 to give a median.
Recalls per year · LGM
No recall names LGM since 2007.
Adverse event reports per year · LGM
1in 2010
MAUDE reports naming product code LGM, 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 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Carecube is a patient isolation unit (PIU) designed for the temporary isolation of patients within a hospital setting to prevent particulate (biological) cross-contamination between user and patient, while enclosing the contaminated patient from the external environment. Device should only be used in a hospital setting. This is for temporary housing of a patient prior to transfer to an appropriate hospital destination. Transfer to a more permanent…
Read the full statement (106 words)
The Carecube is a patient isolation unit (PIU) designed for the temporary isolation of patients within a hospital setting to prevent particulate (biological) cross-contamination between user and patient, while enclosing the contaminated patient from the external environment. Device should only be used in a hospital setting. This is for temporary housing of a patient prior to transfer to an appropriate hospital destination. Transfer to a more permanent hospital setting should occur as soon as possible. The Carecube is designed with features that enable low-moderate complexity medical interventions. This includes the following procedures: blood draw, medication administration, palpating abdomen, cardiac auscultation, and connection to IV line/monitoring cables.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231256 · printed Nov 4, 2026
Cite this page
510(k) Report. “K231256: Carecube Negative Pressure Isolation Chamber.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K231256
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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