510(k) Report

510(k) · Cleared

Cleared

Sigma Series Hyperbaric Chamber

K072427510(k) AbbreviatedCleared Jun 11, 2008287-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

Perry Baromedical Corp. · CBF Chamber, Hyperbaric

Cleared on Jun 11, 2008 as substantially equivalent to K990927 (Perry Baromedical Corp., 1999) and 2 other predicates after a 287-day review. Its family tree reaches back 3 generations to 1983.

Decided
Jun 11, 2008
Review
287 days
Class
Class II
Product code
CBF
Recalls
None
Predicates
3

Its longest line of descent runs back 3 generations to K832127 (1983). 7 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2005: 1 other ancestor2002: 1 other ancestor1995: 2 other ancestorsK832127 · Nautilus Monoplace Hyperbaric Unit · Nautilus Environmedical Systems, Inc. · 1983K974868 · Sigma Plus Monoplace Hyperbaric Chamber · Perry Baromedical Corp. · 1998K990927 · Sigma 3400 Monoplace Hyperbaric Chamber · Perry Baromedical Corp. · 19991980198519901995200020052010
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 2 other ancestors K990927 · Sigma 3400 Monoplace Hyperbaric Chamber · Perry Baromedical Corp. · 1999K974868 · Sigma Plus Monoplace Hyperbaric Chamber · Perry Baromedical Corp. · 1998K832127 · Nautilus Monoplace Hyperbaric Unit · Nautilus Environmedical Systems, Inc. · 19830
  1. Root · 3 generations backK832127 Nautilus Monoplace Hyperbaric UnitNautilus Environmedical Systems, Inc. · 1983
  2. 2 generations backK974868 Sigma Plus Monoplace Hyperbaric ChamberPerry Baromedical Corp. · 1998
  3. 1 generation backK990927 Sigma 3400 Monoplace Hyperbaric ChamberPerry Baromedical Corp. · 1999
  4. This deviceK072427 Sigma Series Hyperbaric ChamberPerry Baromedical Corp. · 2008
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K832127Nautilus Monoplace Hyperbaric UnitNautilus Environmedical Systems, Inc.1983—
−2K974868Sigma Plus Monoplace Hyperbaric ChamberPerry Baromedical Corp.1998—
−1K990927Sigma 3400 Monoplace Hyperbaric ChamberPerry Baromedical Corp.1999—
0 (this device)K072427Sigma Series Hyperbaric ChamberPerry Baromedical Corp.2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199520
200210
200510
FIG. 1 — Lineage of K072427, 1983–2008Source: 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
*K990927Sigma 3400 Monoplace Hyperbaric Chamber
Summary page 1
…Product per 21 CFR § 868.5470 Classification 8. Classification Anesthesiology Panel 9. Predicate Perry Baromedical's, SIGMA 34 (K990927) Devices Sechrist Industry's, Sechrist 3300E/ER (K052713) Enviromnmental Techtonics' BARA-M…
Perry Baromedical Corp.1999—
*K052713Model 3300E/ER Monoplace Hyperbaric Oxygen Chamber
Summary page 1
…lassification Anesthesiology Panel 9. Predicate Perry Baromedical's, SIGMA 34 (K990927) Devices Sechrist Industry's, Sechrist 3300E/ER (K052713) Enviromnmental Techtonics' BARA-MED (K020974) 10. Device The SIGMA slite Series Hyperbaric C…
Sechrist Industries, Inc.20052
*K020974Bara-Med Acrylic Monoplace Hyperbaric Chamber
Summary page 1
…rry Baromedical's, SIGMA 34 (K990927) Devices Sechrist Industry's, Sechrist 3300E/ER (K052713) Enviromnmental Techtonics' BARA-MED (K020974) 10. Device The SIGMA slite Series Hyperbaric Chambers and their predicate devices Description have the s…
Environmental Tectonics Corp.2002—

Also cleared against K990927: 2 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 25 years and passes through 2 companies; a new generation was cleared every 8.6 years on median.
  • 1 of the 7 ancestors has a recall of any class.
  • 2 other devices also cite its predicate K990927.

How does its category compare?

All CBF devices

CBF Chamber, Hyperbaric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

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 SIGMA Elite 34, 36 and 40 Monoplace Hyperbaric Chambers are intended for use for the following clinical medical conditions in accordance with guidelines established by the Undersea and Hyperbaric Medical Society, as follows:

1. Air or Gas Embolism

2. Carbon Monoxide / Smoke Inhalation

3. Compromised Skin Grafts and Flaps

4. Crush Injuries / Acute Traumatic Ischemia

5. Decompression Sickness

6. Enhanced Healing in Selected Problem Wounds

7. Exceptional Blood Loss (Anemia)

8. Gas Gangrene (Clostridia Myonecrosis)

9. Intracranial Abscess

10. Necrotizing Soft Tissue Infections

11. Radiation Tissue Damage (Osteoradionecrosis)

12. Refractory Osteomyelitis

13. Thermal Burns

Indications for use as stated in the FDA summary.

Also cleared against K990927

2 other devices cite the same predicate.

  • K081506Hyperbaric America, LLC, Presidential Monoplace Hyperbaric Chamber SystemsHyperbaric America, LLC · 2008
  • K021693Pan-America Hyperbarics Hyperbaric Chamber System, Model Pah-S1Pan-America Hyperbarics, Inc. · 2002

More from Perry Baromedical Corp.

3 FDA decisions under this applicant name. See the company

  • K990927Sigma 3400 Monoplace Hyperbaric ChamberPerry Baromedical Corp. · 1999
  • K974868Sigma Plus Monoplace Hyperbaric ChamberPerry Baromedical Corp. · 1998

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/K072427 · printed Nov 5, 2026

Cite this page

510(k) Report. “K072427: Sigma Series Hyperbaric Chamber.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072427

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