510(k) Report

510(k) · Cleared

Cleared

MTB 1043 Treatment Booth

K944133510(k) TraditionalCleared Sep 7, 1995379-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

Mark Solutions, Inc. · LGM Chamber, Patient Isolation

Cleared on Sep 7, 1995 after a 379-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Sep 7, 1995
Review
379 days
Class
Class II
Product code
LGM
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K944133Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K231256 Carecube Negative Pressure Isolation Chamberscore 6.9 · 2 generations · no Class I recall
Get a 510(k) Report

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?

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 LGM devices

LGM Chamber, Patient Isolation: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LGM

1in 2024

2009: 12017: 12024: 12026 (partial year): 1
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

2010: 1
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20091—00
20100—01
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20171—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20241—00
20250—00
20261—0—

Recent decisions in LGM

The LGM category page

  • K260180Carecube Negative Pressure Isolation Chamber (1BY)Carecubes, Inc. · 2026
  • K231256Carecube Negative Pressure Isolation ChamberCarecubes, Inc. · 2024
  • K163223ORCA (tm) - Operational Rescue Containment ApparatusIsovac Products, LLC · 2017
  • K080117Patient Isolation Unit, Model G019-1000Gentex Corporation · 2009
  • K022260Failsafe - Portable Infection Control SystemsIsolation Systems, Inc. · 2002

https://510kreport.com/device/K944133 · printed Nov 4, 2026

Cite this page

510(k) Report. “K944133: MTB 1043 Treatment Booth.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K944133

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026