510(k) Report

510(k) · Cleared

Cleared

Model 2500E/2500ER Hyperbaric Chamber

K934164510(k) TraditionalCleared Jun 13, 1995655-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

Sechrist Industries, Inc. · CBF Chamber, Hyperbaric

Cleared on Jun 13, 1995 after a 655-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 8 later devices descend from it.

Decided
Jun 13, 1995
Review
655 days
Class
Class II
Product code
CBF
Recalls
None
Predicates
0

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

Descendants, by year cleared 2002: 2 descendants cleared2011: 1 descendant cleared2000: 1 descendant cleared2008: 2 descendants cleared2005: 1 descendant cleared2006: 1 descendant cleared1995200020052010201520202025
  1. This deviceK934164 Model 2500E/2500ER Hyperbaric ChamberSechrist Industries, Inc. · 1995
  2. Descendant · cites it directly · 3 of its ownK993010 Bara-Med, Acrylic Monoplace Hyperbaric ChamberEnvironmental Tectonics Corp. · 2000
  3. Descendant · cites it directly · 2 of its ownK021693 Pan-America Hyperbarics Hyperbaric Chamber System, Model Pah-S1Pan-America Hyperbarics, Inc. · 2002
  4. Descendant · cites it directly · 2 of its ownK020974 Bara-Med Acrylic Monoplace Hyperbaric ChamberEnvironmental Tectonics Corp. · 2002
  5. Descendant · cites it directly · 0 of its ownK102831 RSI 4200Reimers Systems, Inc. · 2011
  6. Descendant · cites it directly · 0 of its ownK081506 Hyperbaric America, LLC, Presidential Monoplace Hyperbaric Chamber…Hyperbaric America, LLC · 2008

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2000: 12002: 22005: 12006: 12008: 22011: 1
2000high 2 (2002) · low 0 (2001)2026

Most influential descendants

Showing 5 of 8 · See all
  • K993010Bara-Med, Acrylic Monoplace Hyperbaric ChamberEnvironmental Tectonics Corp. · 2000 · cites it directly3descendants
  • K021693Pan-America Hyperbarics Hyperbaric Chamber System, Model Pah-S1Pan-America Hyperbarics, Inc. · 2002 · cites it directly2descendants
  • K020974Bara-Med Acrylic Monoplace Hyperbaric ChamberEnvironmental Tectonics Corp. · 2002 · cites it directly2descendants
  • K102831RSI 4200Reimers Systems, Inc. · 2011 · cites it directly0descendants
  • K081506Hyperbaric America, LLC, Presidential Monoplace Hyperbaric Chamber SystemsHyperbaric America, LLC · 2008 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K934164Model 2500E/2500ER Hyperbaric ChamberSechrist Industries, Inc.1995—
+1K993010Bara-Med, Acrylic Monoplace Hyperbaric ChamberEnvironmental Tectonics Corp.2000—
+1K021693Pan-America Hyperbarics Hyperbaric Chamber System, Model Pah-S1Pan-America Hyperbarics, Inc.2002—
+1K020974Bara-Med Acrylic Monoplace Hyperbaric ChamberEnvironmental Tectonics Corp.2002—
+1K102831RSI 4200Reimers Systems, Inc.2011—
+1K081506Hyperbaric America, LLC, Presidential Monoplace Hyperbaric Chamber SystemsHyperbaric America, LLC2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200010
200220
200510
200610
200820
201110
FIG. 1 — Lineage of K934164, 1995–2011Source: 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? (8)

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

NumberDeviceApplicantDecidedDescendants
K993010Bara-Med, Acrylic Monoplace Hyperbaric ChamberEnvironmental Tectonics Corp.20003
K021693Pan-America Hyperbarics Hyperbaric Chamber System, Model Pah-S1Pan-America Hyperbarics, Inc.20022
K020974Bara-Med Acrylic Monoplace Hyperbaric ChamberEnvironmental Tectonics Corp.20022
K102831RSI 4200Reimers Systems, Inc.20110
K081506Hyperbaric America, LLC, Presidential Monoplace Hyperbaric Chamber SystemsHyperbaric America, LLC20080

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, K993010 (Environmental Tectonics Corp., 2000) has gone furthest, with 3 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 Sechrist Industries, Inc.

23 FDA decisions under this applicant name. See the company

  • K140559Sechrist Monoplace Hyperbaric Oxygen ChamberSechrist Industries, Inc. · 2014
  • K100268Sechrist Monoplace Hyperbaric Oxygen ChamberSechrist Industries, Inc. · 2010
  • K052713Model 3300E/ER Monoplace Hyperbaric Oxygen ChamberSechrist Industries, Inc. · 20052 recalls
  • K023745Sechrist Air/Oxygen Mixer, Model 3500 CP-GSechrist Industries, Inc. · 2003
  • K993167Millennium Infant VentilatorSechrist Industries, Inc. · 1999

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/K934164 · printed Nov 6, 2026

Cite this page

510(k) Report. “K934164: Model 2500E/2500ER Hyperbaric Chamber.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K934164

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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