510(k) · Cleared
ClearedStretcher Transit Isolater #122
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vickers America Medical Corp. · LGM Chamber, Patient Isolation
Cleared on Jul 3, 1979 after an 89-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Jul 3, 1979
- Review
- 89 days
- Class
- Class II
- Product code
- LGM
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK790657 Stretcher Transit Isolater #122Vickers America Medical Corp. · 1979
- Descendant · cites it directly · 2 of its ownK052798 Capsuls, Models 2003-PUR8C, 2004-PVC8CIsovac Products, LLC · 2006
- Descendant · 2 generations on · 0 of its ownK231256 Carecube Negative Pressure Isolation ChamberCarecubes, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK163223 ORCA (tm) - Operational Rescue Containment ApparatusIsovac Products, LLC · 2017
Most influential descendants
Showing 3 of 3 · See all- K052798Capsuls, Models 2003-PUR8C, 2004-PVC8CIsovac Products, LLC · 2006 · cites it directly2descendants
- K231256Carecube Negative Pressure Isolation ChamberCarecubes, Inc. · 2024 · 2 generations on0descendants
- K163223ORCA (tm) - Operational Rescue Containment ApparatusIsovac Products, LLC · 2017 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K790657 | Stretcher Transit Isolater #122 | Vickers America Medical Corp. | 1979 | — |
| +1 | K052798 | Capsuls, Models 2003-PUR8C, 2004-PVC8C | Isovac Products, LLC | 2006 | — |
| +2 | K231256 | Carecube Negative Pressure Isolation Chamber | Carecubes, Inc. | 2024 | — |
| +2 | K163223 | ORCA (tm) - Operational Rescue Containment Apparatus | Isovac Products, LLC | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2017 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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.
Top candidate predicates for a new LGM device
- #1 K231256 Carecube Negative Pressure Isolation Chamberscore 6.9 · 2 generations · no Class I recall
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K052798 | Capsuls, Models 2003-PUR8C, 2004-PVC8C | 2006 | 2 |
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?
- Of its descendants, K052798 (Isovac Products, LLC, 2006) has gone furthest, with 2 descendants of its own.
How does its category compare?
All LGM devicesLGM Chamber, Patient Isolation: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K790657 · printed Nov 6, 2026
Cite this page
510(k) Report. “K790657: Stretcher Transit Isolater #122.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K790657
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026