510(k) Report

510(k) · Cleared

Cleared

Multiplace Hyperbaric System, Model Mmi Hyperbaric Chamber System

K030418510(k) TraditionalCleared Jan 29, 2004353-day reviewClass II21 CFR 868.5470

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

Makai Marine Industries, Inc. · CBF Chamber, Hyperbaric

Cleared on Jan 29, 2004 as substantially equivalent to K930748 (Perry Baromedical Services, 1993) and 3 other predicates after a 353-day review. Its family tree reaches back 2 generations to 1986.

Decided
Jan 29, 2004
Review
353 days
Class
Class II
Product code
CBF
Recalls
None
Predicates
4

Its longest line of descent runs back 2 generations to K862198 (1986). 5 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1995: 2 other ancestors1993: 1 other ancestorK862198 · Sigma II - Dual Place Hyperbaric Chamber · Perry Baromedical Services · 1986K960389 · Hyperbaric Chamber · Tampa Hyperbaric Ent. · 199619851990199520002005
Other ancestors, by generation 1 generation back: 3 other ancestors K960389 · Hyperbaric Chamber · Tampa Hyperbaric Ent. · 1996K862198 · Sigma II - Dual Place Hyperbaric Chamber · Perry Baromedical Services · 19860
  1. Root · 2 generations backK862198 Sigma II - Dual Place Hyperbaric ChamberPerry Baromedical Services · 1986
  2. 1 generation backK960389 Hyperbaric ChamberTampa Hyperbaric Ent. · 1996
  3. This deviceK030418 Multiplace Hyperbaric System, Model Mmi Hyperbaric Chamber SystemMakai Marine Industries, Inc. · 2004
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K862198Sigma II - Dual Place Hyperbaric ChamberPerry Baromedical Services1986—
−1K960389Hyperbaric ChamberTampa Hyperbaric Ent.1996—
0 (this device)K030418Multiplace Hyperbaric System, Model Mmi Hyperbaric Chamber SystemMakai Marine Industries, Inc.2004—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199310
199520
FIG. 1 — Lineage of K030418, 1986–2004Source: FDA 510(k) summaries, read by 510(k) Report · 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), 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 CBF? 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 CBF device

  1. #1 K240569 FESL FINK Chamber; FEDL FINK Chamber; FETL…score 8.7 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (4)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K930748Sigma MP Multiplace Hyperbaric Chamber
Summary page 1
…Chamber CLASSIFICATION: 73 CBF, 21 CFR 868.5470 ESTABLISHMENT REGISTRATION NUMBER: 1063240 CLAIMED PREDICATE DEVICE(S): Perry Sigma MP Multiplace Hyperbaric Chamber - K930748 Gulf Coast Hyperbarics Multiplace Hyperbaric Chamber - K950957 Reimers T Class Hyperbaric Facility - K95438 Tampa Hyperbaric E…
Perry Baromedical Services1993—
*K950957Multiplace Hyperbaric Treatment Chamber System
Summary page 1
…EGISTRATION NUMBER: 1063240 CLAIMED PREDICATE DEVICE(S): Perry Sigma MP Multiplace Hyperbaric Chamber - K930748 Gulf Coast Hyperbarics Multiplace Hyperbaric Chamber - K950957 Reimers T Class Hyperbaric Facility - K95438 Tampa Hyperbaric Enterprises' Multiplace Hyperbaric Chamber - K960389 ADDRESS O…
Gulf Coast Hyperbarics, Inc.1995—
*K954387T Class Hyperbaric Facilities
Summary page 3
…s' Hyperbaric Chamber (K960389); the Gulf Coast Hyperbarics, Inc. Multiplace Hyperbaric Treatment System (K950957); the Reimers Engineering T Class Hyperbaric Facility (K954387) and is proposing them as predicate devices for the MMI Hyperbaric Chamber System. INTENDED USE: It is the expressed, intended…
Reimers Systems, Inc.1995—
*K960389Hyperbaric Chamber
Summary page 1
…lf Coast Hyperbarics Multiplace Hyperbaric Chamber - K950957 Reimers T Class Hyperbaric Facility - K95438 Tampa Hyperbaric Enterprises' Multiplace Hyperbaric Chamber - K960389 ADDRESS OF MANUFACTURER: Makai Marine Industries, Inc. P.…
Tampa Hyperbaric Ent.1996—

Also cleared against K930748: 6 other devices →

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 18 years and passes through 3 companies; a new generation was cleared every 10.1 years on median.
  • None of the 5 ancestors has a recall.
  • 6 other devices also cite its predicate K930748.

How does its category compare?

All CBF devices

CBF Chamber, Hyperbaric: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CBF

1in 2024

2008: 32009: 12010: 32011: 12014: 12016: 12017: 12019: 12023: 12024: 1
2007high 3 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CBF

87in 2010

2008: 134 days median2010: 87 days median
2007high 134 (2008) · low 87 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · CBF

2in 2008

2008: 2
2007high 2 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · CBF

25in 2025

2007: 22009: 12010: 112011: 52012: 92013: 12014: 52015: 32016: 52017: 92018: 52019: 32020: 42021: 62022: 92023: 132024: 132025: 25
2007high 25 (2025) · low 0 (2008)2025

MAUDE reports naming product code CBF, 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—02
2008313420
20091—01
2010387011
20111—05
20120—09
20130—01
20141—05
20150—03
20161—05
20171—09
20180—05
20191—03
20200—04
20210—06
20220—09
20231—013
20241—013
20250—025
20260—0—

What is it indicated for?

The conditions listed as appropriate for the use of (HBO) in the current edition of the Hyperbaric Oxygen Therapy Committee Report (1999) are as follows: 1. Air or gas embolism 2. Carbon monoxide poisoning and carbon monoxide poisoning complicated by cyanide poisoning 3. Clostridial myositis and Myonecrosis (Gas Gangrene) 4. Crush injury, compartment syndrome, and other acute traumatic lschemias 5. Decompression sickness 6. Enhanced healing of selected…

Read the full statement (104 words)

The conditions listed as appropriate for the use of (HBO) in the current edition of the Hyperbaric Oxygen Therapy Committee Report (1999) are as follows:

1. Air or gas embolism

2. Carbon monoxide poisoning and carbon monoxide poisoning complicated by cyanide poisoning

3. Clostridial myositis and Myonecrosis (Gas Gangrene)

4. Crush injury, compartment syndrome, and other acute traumatic lschemias

5. Decompression sickness

6. Enhanced healing of selected problem wounds

7. Exceptional blood loss anemia

8. Necrotizing soft tissue infections

9. Osteomyelitis (refractory)

i0. Delayed radiation injury (soft tissue and bony necrosis)

i 1. Skin grafts and flaps (compromised)

12. Thermal burns

13. Intracranial abscess

Indications for use as stated in the FDA summary.

Also cleared against K930748

6 other devices cite the same predicate.

  • K082455Rectangular Multiplace Hyperbaric ChamberGulf Coast Hyperbarics, Inc. · 2009
  • K053498Hyperox 101Wjo, Inc. · 2006
  • K031649SL8/DL8/TL20 Hyperbaric Oxygen Treatment FacilitiesFink Engineering Pty, Ltd. · 2003
  • K021689Pan-America Hyperbarics, Hyperbaric Chamber System, Model Pah-M10+2Pan-America Hyperbarics, Inc. · 2002
  • K011866Oxyheal 2000 Hyperbaric Chamber Series, Model Oxyheal 2000 SeriesHyperbaric Technologies, Inc. · 2002
  • K960389Hyperbaric ChamberTampa Hyperbaric Ent. · 1996

Recent decisions in CBF

The CBF category page

  • K240569FESL FINK Chamber; FEDL FINK Chamber; FETL FINK ChamberFink Engineering Pty, Ltd. · 2024
  • K220290Revitalair 430+Us Hyperbaric Network · 2023
  • K171899Revitalair 430FOxavita Srl · 2019
  • K163109OxyHeal 4000 Multiplace Hyperbaric Chamber FamilyOxyheal Medical Systems, Inc. · 2017
  • K152223Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control SystemOxyheal Medical Systems, Inc. · 2016

https://510kreport.com/device/K030418 · printed Nov 6, 2026

Cite this page

510(k) Report. “K030418: Multiplace Hyperbaric System, Model Mmi Hyperbaric Chamber System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030418

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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