510(k) · Cleared
ClearedCapsuls, Models 2003-PUR8C, 2004-PVC8C
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Isovac Products, LLC · LGN Chamber, Patient Transport Isolation
Cleared on Jun 6, 2006 as substantially equivalent to K790657 (Vickers America Medical Corp., 1979) after a 246-day review. Its family tree reaches back 1 generation to 1979. 2 later devices descend from it.
- Decided
- Jun 6, 2006
- Review
- 246 days
- Class
- Class II
- Product code
- LGN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K790657 (1979). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK790657 Stretcher Transit Isolater #122Vickers America Medical Corp. · 1979
- This deviceK052798 Capsuls, Models 2003-PUR8C, 2004-PVC8CIsovac Products, LLC · 2006
- Descendant · cites it directly · 0 of its ownK231256 Carecube Negative Pressure Isolation ChamberCarecubes, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK163223 ORCA (tm) - Operational Rescue Containment ApparatusIsovac Products, LLC · 2017
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K790657 | Stretcher Transit Isolater #122 | Vickers America Medical Corp. | 1979 | — |
| 0 (this device) | K052798 | Capsuls, Models 2003-PUR8C, 2004-PVC8C | Isovac Products, LLC | 2006 | — |
| +1 | K231256 | Carecube Negative Pressure Isolation Chamber | Carecubes, Inc. | 2024 | — |
| +1 | K163223 | ORCA (tm) - Operational Rescue Containment Apparatus | Isovac Products, LLC | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2024 | 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 LGN? 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 |
|---|---|---|---|
| * | K790657 | Stretcher Transit Isolater #122Summary page 1…450, Product Code LGM) Legally Marketed Device to which Equivalence is Claimed: The legally marketed predicate device is the Aircraft Transport Isolator (K790657) manufactured by Vickers America Medical Corporation, determined to be substantially equivalent to a legally marketed (preAmendme… | 1979 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Its one ancestor has no recall.
- Of its descendants, K231256 (Carecubes, Inc., 2024) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LGN devicesLGN Chamber, Patient Transport Isolation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LGN
FDA has decided no LGN device since 2007.
Median 510(k) review, days · LGN
Too few LGN 510(k)s in any year since 2007 to give a median.
Recalls per year · LGN
No recall names LGN since 2007.
Adverse event reports per year · LGN
No MAUDE report names LGN since 2007.
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 | 0 | — | 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 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 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 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The CAPSULSTM (Containment and Protection System Utilizing Life Support) is a portable Patient Isolation Unit (PIU), which prevents particulate (biological and radiological) cross-contamination between the patient and the external environment; and with features that enable medical intervention to the patient via end-user supplied medical equipment. The CAPSULS is intended to be used for:
* The transport and isolation of patients on aircraft, ambulances, ships, and any vehicle capable of safely transporting a patient on a standard litter,
- The temporary isolation, with or without transport, of patients within hospitals or other medical facilities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052798 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052798: Capsuls, Models 2003-PUR8C, 2004-PVC8C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052798
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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