510(k) Report

510(k) · Cleared

Cleared

Pan-America Hyperbarics Hyperbaric Chamber System, Model Pah-S1

K021693510(k) AbbreviatedCleared Oct 24, 2002155-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

Pan-America Hyperbarics, Inc. · CBF Chamber, Hyperbaric

Cleared on Oct 24, 2002 as substantially equivalent to K934164 (Sechrist Industries, Inc., 1995) and 6 other predicates after a 155-day review. Its family tree reaches back 3 generations to 1983. 2 later devices descend from it.

Decided
Oct 24, 2002
Review
155 days
Class
Class II
Product code
CBF
Recalls
None
Predicates
7

Its longest line of descent runs back 3 generations to K832127 (1983). 9 ancestors in all. 2 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 2 other ancestors1999: 1 other ancestor1995: 2 other ancestors1986: 1 other ancestor2008: 1 descendant cleared2006: 1 descendant clearedK832127 · 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. · 199919801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors2 generations back: 1 other ancestor 1 generation forward: 2 descendants 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 deviceK021693 Pan-America Hyperbarics Hyperbaric Chamber System, Model Pah-S1Pan-America Hyperbarics, Inc. · 2002
  5. Descendant · cites it directly · 0 of its ownK081506 Hyperbaric America, LLC, Presidential Monoplace Hyperbaric Chamber…Hyperbaric America, LLC · 2008
  6. Descendant · cites it directly · 0 of its ownK053498 Hyperox 101Wjo, Inc. · 2006

Most influential descendants

Showing 2 of 2 · See all
  • K081506Hyperbaric America, LLC, Presidential Monoplace Hyperbaric Chamber SystemsHyperbaric America, LLC · 2008 · cites it directly0descendants
  • K053498Hyperox 101Wjo, Inc. · 2006 · cites it directly0descendants
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)K021693Pan-America Hyperbarics Hyperbaric Chamber System, Model Pah-S1Pan-America Hyperbarics, Inc.2002—
+1K081506Hyperbaric America, LLC, Presidential Monoplace Hyperbaric Chamber SystemsHyperbaric America, LLC2008—
+1K053498Hyperox 101Wjo, Inc.2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198610
199520
199910
200020

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200810
FIG. 1 — Lineage of K021693, 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? (7)

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
*K934164Model 2500E/2500ER Hyperbaric Chamber
Summary page 1
…: Monoplace Hyperbaric Chamber CLASSIFICATION: 73 CBF, 21 CFR 868.5470 ESTABLISHMENT REGISTRATION NUMBER: Pending CLAIMED PREDICATE DEVICE(S): Sechrist 2500 (K934164) Sechrist 2800 (K950386) Sechrist 3200 (K950386) Perry Sigma 1 (K832127) Perry Sigma 34 (K990927)…
Sechrist Industries, Inc.1995—
*K950386Model 3200P/3200PR Hyperbaric Chamber
Summary page 1
…CLASSIFICATION: 73 CBF, 21 CFR 868.5470 ESTABLISHMENT REGISTRATION NUMBER: Pending CLAIMED PREDICATE DEVICE(S): Sechrist 2500 (K934164) Sechrist 2800 (K950386) Sechrist 3200 (K950386) Perry Sigma 1 (K832127) Perry Sigma 34 (K990927) ETC BaraMed (K993010)…
Sechrist Industries, Inc.1995—
*K832127Nautilus Monoplace Hyperbaric Unit
Summary page 1
…ION NUMBER: Pending CLAIMED PREDICATE DEVICE(S): Sechrist 2500 (K934164) Sechrist 2800 (K950386) Sechrist 3200 (K950386) Perry Sigma 1 (K832127) Perry Sigma 34 (K990927) ETC BaraMed (K993010) Tampa Hyperbarics “T.H.E.” Chamber (K981938) Hype…
Nautilus Environmedical Systems, Inc.1983—
*K990927Sigma 3400 Monoplace Hyperbaric Chamber
Summary page 1
…ICATE DEVICE(S): Sechrist 2500 (K934164) Sechrist 2800 (K950386) Sechrist 3200 (K950386) Perry Sigma 1 (K832127) Perry Sigma 34 (K990927) ETC BaraMed (K993010) Tampa Hyperbarics “T.H.E.” Chamber (K981938) HyperTec 3200 (K002795) ADDRESS OF M…
Perry Baromedical Corp.1999—
*K993010Bara-Med, Acrylic Monoplace Hyperbaric Chamber
Summary page 1
…rist 2500 (K934164) Sechrist 2800 (K950386) Sechrist 3200 (K950386) Perry Sigma 1 (K832127) Perry Sigma 34 (K990927) ETC BaraMed (K993010) Tampa Hyperbarics “T.H.E.” Chamber (K981938) HyperTec 3200 (K002795) ADDRESS OF MANUFACTURER: Pan-Amer…
Environmental Tectonics Corp.2000—
*K981938Tampa Hyperbaric Monoplace Chamber
Summary page 1
…Sechrist 3200 (K950386) Perry Sigma 1 (K832127) Perry Sigma 34 (K990927) ETC BaraMed (K993010) Tampa Hyperbarics “T.H.E.” Chamber (K981938) HyperTec 3200 (K002795) ADDRESS OF MANUFACTURER: Pan-America Hyperbarics, Inc. No. 9, Lane 12, Guang F…
Tampa Hyperbaric Ent.1999—
*K002795Model Hybrid 3200 Monoplace, Hyperbaric Therapy Systems
Summary page 1
…Perry Sigma 1 (K832127) Perry Sigma 34 (K990927) ETC BaraMed (K993010) Tampa Hyperbarics “T.H.E.” Chamber (K981938) HyperTec 3200 (K002795) ADDRESS OF MANUFACTURER: Pan-America Hyperbarics, Inc. No. 9, Lane 12, Guang Feng 1“ Street Ba-de City…
Hypertec, Inc.2000—

Also cleared against K934164: 4 other devices →

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K081506Hyperbaric America, LLC, Presidential Monoplace Hyperbaric Chamber SystemsHyperbaric America, LLC20080
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?

  • The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
  • None of the 9 ancestors has a recall.
  • Of its descendants, K081506 (Hyperbaric America, LLC, 2008) has gone furthest, with 0 descendants of its own.
  • 4 other devices also cite its predicate K934164.

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

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

5. Decompression sickness

6. Enhanced healing of selected problem wounds

7. Exceptional blood loss 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 K934164

4 other devices cite the same predicate.

  • K102831RSI 4200Reimers Systems, Inc. · 2011
  • K081506Hyperbaric America, LLC, Presidential Monoplace Hyperbaric Chamber SystemsHyperbaric America, LLC · 2008
  • K020974Bara-Med Acrylic Monoplace Hyperbaric ChamberEnvironmental Tectonics Corp. · 2002
  • K993010Bara-Med, Acrylic Monoplace Hyperbaric ChamberEnvironmental Tectonics Corp. · 2000

More from Pan-America Hyperbarics, Inc.

4 FDA decisions under this applicant name. See the company

  • K122560Versalvent Model V1 Hyperbaric Chamber Ventilator Model V1Pan-America Hyperbarics, Inc. · 2013
  • K021690Pan-America Hyperbarics Hyperbaric Chamber System, Model Pah-M3+1Pan-America Hyperbarics, Inc. · 2002
  • K021689Pan-America Hyperbarics, Hyperbaric Chamber System, Model Pah-M10+2Pan-America Hyperbarics, Inc. · 2002

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/K021693 · printed Nov 4, 2026

Cite this page

510(k) Report. “K021693: Pan-America Hyperbarics Hyperbaric Chamber System, Model Pah-S1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021693

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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