510(k) · Cleared

Cleared

ORCA (tm) - Operational Rescue Containment Apparatus

K163223510(k) TraditionalCleared Nov 2, 2017351-day reviewClass II21 CFR 880.5450

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Isovac Products, LLC · LGM Chamber, Patient Isolation

Cleared on Nov 2, 2017 as substantially equivalent to K052798 (Isovac Products, LLC, 2006) after a 351-day review. Its family tree reaches back 2 generations to 1979.

Decided: Nov 2, 2017
Review: 351 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.

By dateBy generation

Root · 2 generations backK790657 Stretcher Transit Isolater #122Vickers America Medical Corp. · 1979
1 generation backK052798 Capsuls, Models 2003-PUR8C, 2004-PVC8CIsovac Products, LLC · 2006
This deviceK163223 ORCA (tm) - Operational Rescue Containment ApparatusIsovac Products, LLC · 2017

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K790657	Stretcher Transit Isolater #122	Vickers America Medical Corp.	1979	—
−1	K052798	Capsuls, Models 2003-PUR8C, 2004-PVC8C	Isovac Products, LLC	2006	—
0 (this device)	K163223	ORCA (tm) - Operational Rescue Containment Apparatus	Isovac Products, LLC	2017	—

FIG. 1 — Lineage of K163223, 1979–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

Top candidate predicates for a new LGM device

#1 K231256 Carecube Negative Pressure Isolation Chamberscore 6.9 · 2 generations · no Class I recall

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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	Applicant	Decided	Recalls
*	K052798	Capsuls, Models 2003-PUR8C, 2004-PVC8C Summary page 4 …II (21 CFR 880.5450) Product Code: LGN Predicate Device: The legally marketed predicate device is the CAPSULS Patient Isolation Unit (K052798) manufactured by ISOVAC Products. Device Description: The Operational Rescue Containment Apparatus (ORCA™) Pat…	Isovac Products, LLC	2006	—

Also cleared against K052798: 1 other device →

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 38 years and passes through 2 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 devices

LGM Chamber, Patient Isolation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.

FDA decisions per year · LGM

1in 2024

2007high 1 (2009) · low 0 (2007)2026

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

2007high 1 (2010) · low 0 (2007)2025

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	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	1	—	0
2010	0	—	1
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	1	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	0
2024	1	—	0
2025	0	—	0
2026	1	—	—

What is it indicated for?

The Model ORCA-2016CN is a portable and ambulatory Patient Isolation Unit (PIU) designed to prevent chemical and particulate (biological and radiological) cross-contamination between an enclosed contaminated patient and the external environment during evacuation and transport activities.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K163223 · printed Nov 4, 2026

Cite this page

510(k) Report. “K163223: ORCA (tm) - Operational Rescue Containment Apparatus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K163223

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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