510(k) Report

510(k) · Cleared

Cleared

SL8/DL8/TL20 Hyperbaric Oxygen Treatment Facilities

K031649510(k) AbbreviatedCleared Dec 5, 2003191-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

Fink Engineering Pty, Ltd. · CBF Chamber, Hyperbaric

Cleared on Dec 5, 2003 as substantially equivalent to K930748 (Perry Baromedical Services, 1993) and 2 other predicates after a 191-day review. Its family tree reaches back 1 generation to 1993. 5 later devices descend from it.

Decided
Dec 5, 2003
Review
191 days
Class
Class II
Product code
CBF
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K930748 (1993). 3 ancestors in all. 5 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1995: 2 other ancestors2009: 1 descendant cleared2024: 1 descendant cleared2016: 1 descendant cleared2006: 1 descendant cleared2017: 1 descendant clearedK930748 · Sigma MP Multiplace Hyperbaric Chamber · Perry Baromedical Services · 19931990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 4 descendants2 generations forward: 1 descendant K930748 · Sigma MP Multiplace Hyperbaric Chamber · Perry Baromedical Services · 19930
  1. Root · 1 generation backK930748 Sigma MP Multiplace Hyperbaric ChamberPerry Baromedical Services · 1993
  2. This deviceK031649 SL8/DL8/TL20 Hyperbaric Oxygen Treatment FacilitiesFink Engineering Pty, Ltd. · 2003
  3. Descendant · cites it directly · 1 of its ownK152223 Rectangular Multiplace Hyperbaric Chamber System Product Family with…Oxyheal Medical Systems, Inc. · 2016
  4. Descendant · cites it directly · 0 of its ownK240569 FESL FINK Chamber; FEDL FINK Chamber; FETL FINK ChamberFink Engineering Pty, Ltd. · 2024
  5. Descendant · 2 generations on · 0 of its ownK163109 OxyHeal 4000 Multiplace Hyperbaric Chamber FamilyOxyheal Medical Systems, Inc. · 2017
  6. Descendant · cites it directly · 0 of its ownK082455 Rectangular Multiplace Hyperbaric ChamberGulf Coast Hyperbarics, Inc. · 2009
  7. Descendant · cites it directly · 0 of its ownK053498 Hyperox 101Wjo, Inc. · 2006

Most influential descendants

Showing 5 of 5 · See all
  • K152223Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control…Oxyheal Medical Systems, Inc. · 2016 · cites it directly1descendant
  • K240569FESL FINK Chamber; FEDL FINK Chamber; FETL FINK ChamberFink Engineering Pty, Ltd. · 2024 · cites it directly0descendants
  • K163109OxyHeal 4000 Multiplace Hyperbaric Chamber FamilyOxyheal Medical Systems, Inc. · 2017 · 2 generations on0descendants
  • K082455Rectangular Multiplace Hyperbaric ChamberGulf Coast Hyperbarics, Inc. · 2009 · cites it directly0descendants
  • K053498Hyperox 101Wjo, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K930748Sigma MP Multiplace Hyperbaric ChamberPerry Baromedical Services1993—
0 (this device)K031649SL8/DL8/TL20 Hyperbaric Oxygen Treatment FacilitiesFink Engineering Pty, Ltd.2003—
+1K152223Rectangular Multiplace Hyperbaric Chamber System Product Family with…Oxyheal Medical Systems, Inc.2016—
+1K240569FESL FINK Chamber; FEDL FINK Chamber; FETL FINK ChamberFink Engineering Pty, Ltd.2024—
+2K163109OxyHeal 4000 Multiplace Hyperbaric Chamber FamilyOxyheal Medical Systems, Inc.2017—
+1K082455Rectangular Multiplace Hyperbaric ChamberGulf Coast Hyperbarics, Inc.2009—
+1K053498Hyperox 101Wjo, Inc.2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199520

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200910
201610
201710
202410
FIG. 1 — Lineage of K031649, 1993–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (3)

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
…CLASSIFICATION: 73 CBF, 21 CFR 868.5470 ESTABLISHMENT REGISTRATION NUMBER: Pending CLAIMED PREDICATE DEVICE(S): Perry Sigma MP Multiplace Hyperbaric Chamber - K930748 Gulf Coast Multiplace Hyperbaric Chamber - K950957 Reimers T Class Hyperbaric Chamber - K954387 ADDRESS OF MANUF…
Perry Baromedical Services1993—
*K950957Multiplace Hyperbaric Treatment Chamber System
Summary page 1
…STRATION NUMBER: Pending CLAIMED PREDICATE DEVICE(S): Perry Sigma MP Multiplace Hyperbaric Chamber - K930748 Gulf Coast Multiplace Hyperbaric Chamber - K950957 Reimers T Class Hyperbaric Chamber - K954387 ADDRESS OF MANUFACTURER: Fink Engineering PTY LTD…
Gulf Coast Hyperbarics, Inc.1995—
*K954387T Class Hyperbaric Facilities
Summary page 1
…: Perry Sigma MP Multiplace Hyperbaric Chamber - K930748 Gulf Coast Multiplace Hyperbaric Chamber - K950957 Reimers T Class Hyperbaric Chamber - K954387 ADDRESS OF MANUFACTURER: Fink Engineering PTY LTD 100 Talinga Road…
Reimers Systems, Inc.1995—

Also cleared against K930748: 6 other devices →

What descends from it? (5)

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

NumberDeviceApplicantDecidedDescendants
K152223Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control…Oxyheal Medical Systems, Inc.20161
K240569FESL FINK Chamber; FEDL FINK Chamber; FETL FINK ChamberFink Engineering Pty, Ltd.20240
K082455Rectangular Multiplace Hyperbaric ChamberGulf Coast Hyperbarics, Inc.20090
K053498Hyperox 101Wjo, Inc.20060

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?

  • None of the 3 ancestors has a recall.
  • Of its descendants, K152223 (Oxyheal Medical Systems, Inc., 2016) has gone furthest, with 1 descendant of its own.
  • 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?

1. Air or gas embolism

2. Carbon monoxide poisoning and carbon monoxide poisoning

complicated by cyanide poisoning

3. Clostridial myositis and myonecrosis

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

ischemias

5. Decompression sickness

6. Enhanced healing of selected problem wounds

7. Exceptional anemia

8. Necrotizing soft tissue infections

9. Osteomyelitis (refractory)

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

11. 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
  • K030418Multiplace Hyperbaric System, Model Mmi Hyperbaric Chamber SystemMakai Marine Industries, Inc. · 2004
  • 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

More from Fink Engineering Pty, Ltd.

2 FDA decisions under this applicant name. See the company

  • K240569FESL FINK Chamber; FEDL FINK Chamber; FETL FINK ChamberFink Engineering Pty, Ltd. · 2024

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/K031649 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031649: SL8/DL8/TL20 Hyperbaric Oxygen Treatment Facilities.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031649

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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