510(k) Report

510(k) · Cleared

Cleared

Multiplace Hyperbaric Treatment Chamber System

K950957510(k) TraditionalCleared Jun 2, 199592-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

Gulf Coast Hyperbarics, Inc. · CBF Chamber, Hyperbaric

Cleared on Jun 2, 1995 after a 92-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 10 later devices descend from it.

Decided
Jun 2, 1995
Review
92 days
Class
Class II
Product code
CBF
Recalls
None
Predicates
0

10 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2009: 1 descendant cleared2003: 1 descendant cleared2002: 2 descendants cleared2004: 1 descendant cleared2016: 1 descendant cleared2005: 1 descendant cleared2024: 1 descendant cleared2006: 1 descendant cleared2017: 1 descendant cleared1995200020052010201520202025
  1. This deviceK950957 Multiplace Hyperbaric Treatment Chamber SystemGulf Coast Hyperbarics, Inc. · 1995
  2. Descendant · cites it directly · 5 of its ownK031649 SL8/DL8/TL20 Hyperbaric Oxygen Treatment FacilitiesFink Engineering Pty, Ltd. · 2003
  3. Descendant · cites it directly · 3 of its ownK011866 Oxyheal 2000 Hyperbaric Chamber Series, Model Oxyheal 2000 SeriesHyperbaric Technologies, Inc. · 2002
  4. Descendant · 2 generations on · 1 of its ownK152223 Rectangular Multiplace Hyperbaric Chamber System Product Family with…Oxyheal Medical Systems, Inc. · 2016
  5. Descendant · 2 generations on · 0 of its ownK240569 FESL FINK Chamber; FEDL FINK Chamber; FETL FINK ChamberFink Engineering Pty, Ltd. · 2024
  6. Descendant · 3 generations on · 0 of its ownK163109 OxyHeal 4000 Multiplace Hyperbaric Chamber FamilyOxyheal Medical Systems, Inc. · 2017

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2002: 22003: 12004: 12005: 12006: 12009: 12016: 12017: 12024: 1
2002high 2 (2002) · low 0 (2007)2026

Most influential descendants

Showing 5 of 10 · See all
  • K031649SL8/DL8/TL20 Hyperbaric Oxygen Treatment FacilitiesFink Engineering Pty, Ltd. · 2003 · cites it directly5descendants
  • K011866Oxyheal 2000 Hyperbaric Chamber Series, Model Oxyheal 2000 SeriesHyperbaric Technologies, Inc. · 2002 · cites it directly3descendants
  • K152223Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control…Oxyheal Medical Systems, Inc. · 2016 · 2 generations on1descendant
  • K240569FESL FINK Chamber; FEDL FINK Chamber; FETL FINK ChamberFink Engineering Pty, Ltd. · 2024 · 2 generations on0descendants
  • K163109OxyHeal 4000 Multiplace Hyperbaric Chamber FamilyOxyheal Medical Systems, Inc. · 2017 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K950957Multiplace Hyperbaric Treatment Chamber SystemGulf Coast Hyperbarics, Inc.1995—
+1K031649SL8/DL8/TL20 Hyperbaric Oxygen Treatment FacilitiesFink Engineering Pty, Ltd.2003—
+1K011866Oxyheal 2000 Hyperbaric Chamber Series, Model Oxyheal 2000 SeriesHyperbaric Technologies, Inc.2002—
+2K152223Rectangular Multiplace Hyperbaric Chamber System Product Family with…Oxyheal Medical Systems, Inc.2016—
+2K240569FESL FINK Chamber; FEDL FINK Chamber; FETL FINK ChamberFink Engineering Pty, Ltd.2024—
+3K163109OxyHeal 4000 Multiplace Hyperbaric Chamber FamilyOxyheal Medical Systems, Inc.2017—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200220
200310
200410
200510
200610
200910
201610
201710
202410
FIG. 1 — Lineage of K950957, 1995–2024Source: 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), 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (10)

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K031649SL8/DL8/TL20 Hyperbaric Oxygen Treatment FacilitiesFink Engineering Pty, Ltd.20035
K011866Oxyheal 2000 Hyperbaric Chamber Series, Model Oxyheal 2000 SeriesHyperbaric Technologies, Inc.20023
K082455Rectangular Multiplace Hyperbaric ChamberGulf Coast Hyperbarics, Inc.20090
K030418Multiplace Hyperbaric System, Model Mmi Hyperbaric Chamber SystemMakai Marine Industries, Inc.20040
K021689Pan-America Hyperbarics, Hyperbaric Chamber System, Model Pah-M10+2Pan-America Hyperbarics, Inc.20020

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, K031649 (Fink Engineering Pty, Ltd., 2003) has gone furthest, with 5 descendants of its own.

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—

More from Gulf Coast Hyperbarics, Inc.

3 FDA decisions under this applicant name. See the company

  • K082455Rectangular Multiplace Hyperbaric ChamberGulf Coast Hyperbarics, Inc. · 2009
  • K011565Infant Oxygen Treatment HoodGulf Coast Hyperbarics, Inc. · 2001

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/K950957 · printed Nov 6, 2026

Cite this page

510(k) Report. “K950957: Multiplace Hyperbaric Treatment 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/K950957

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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