510(k) Report

510(k) · Cleared

Cleared

Sands Series Iii Hyperbaric Chamber

K972908510(k) TraditionalCleared Jul 22, 1998350-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

Sands Hyperbarics · CBF Chamber, Hyperbaric

Cleared on Jul 22, 1998 as substantially equivalent to K840841 (Reneau, Inc., 1984) and 1 other predicate after a 350-day review. Its family tree reaches back 1 generation to 1984.

Decided
Jul 22, 1998
Review
350 days
Class
Class II
Product code
CBF
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K840841 (1984). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1995: 1 other ancestorK840841 · Reneau Unit · Reneau, Inc. · 198419801985199019952000
Other ancestors, by generation 1 generation back: 1 other ancestor K840841 · Reneau Unit · Reneau, Inc. · 19840
  1. Root · 1 generation backK840841 Reneau UnitReneau, Inc. · 1984
  2. This deviceK972908 Sands Series Iii Hyperbaric ChamberSands Hyperbarics · 1998
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K840841Reneau UnitReneau, Inc.1984—
0 (this device)K972908Sands Series Iii Hyperbaric ChamberSands Hyperbarics1998—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
FIG. 1 — Lineage of K972908, 1984–1998Source: 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), 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? (2)

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
*K840841Reneau Unit
Summary page 1
…ERBARIC OXYGEN CHAMBER C.F.R.No.: 868.5470 510 (k) Number: K972908 §807.92 (a) (3). Equivalent Device #1 Reneau Unit (since renamed the PROTEUS CHAMBER)* 510 (k) No.: K840841 Decision Date: 08/07/84 Equivalent Device #2 Sechrist Model 3200P/3200PR Hyperbaric Chamber 510 (k) No.: K950386 Decision Date:…
Reneau, Inc.1984—
*K950386Model 3200P/3200PR Hyperbaric Chamber
Summary page 1
…Unit (since renamed the PROTEUS CHAMBER)* 510 (k) No.: K840841 Decision Date: 08/07/84 Equivalent Device #2 Sechrist Model 3200P/3200PR Hyperbaric Chamber 510 (k) No.: K950386 Decision Date: 06/13/95 * see Exhibit A §807.92 (a) (4). DESCRIPTION OF THE DEVICE A hyperbaric oxygen treatme…
Sechrist Industries, Inc.1995—

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?

  • None of the 2 ancestors has a recall.

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?

APPROVED USES AND THRESHOLD LEVELS FOR THE NUMBER OF HYPERBARIC TREATMENTS (As published by the Undersea and Hyperbaric Medical Society's (UHMS) Oxygen Committee 1995) INDICATIONS Threshold Levels 1. Air or Gas Embolism 14 2. Carbon Monoxide Poisoning and Smoke Inhalation 10 3. Clostridial Myonecrosis (Gas Gangrene) 5* - 10 - 4. Crush Injury, Compartment Syndrome and Other Acute Traumatic 3* - 12 Ischemias 5. Decompression Sickness Until improvement…

Read the full statement (131 words)

APPROVED USES AND THRESHOLD LEVELS FOR THE NUMBER OF HYPERBARIC TREATMENTS

(As published by the Undersea and Hyperbaric Medical Society's (UHMS) Oxygen Committee 1995)

INDICATIONS Threshold Levels

1. Air or Gas Embolism 14

2. Carbon Monoxide Poisoning and Smoke Inhalation 10

3. Clostridial Myonecrosis (Gas Gangrene) 5* - 10 -

4. Crush Injury, Compartment Syndrome and Other Acute Traumatic 3* - 12

Ischemias

5. Decompression Sickness Until improvement plateaus

or 14 days

6. Enhanced Healing in Selected Problem Wounds 10* - 60

7. Exceptional Blood Loss (anemia) Until HCT 22.9%

8. Necrotizing Soft Tissue Infections (Subcutaneous Tissue, Muscle, Fascia) 5* - 30

9. Osteomyelitis (refractory) 20* - 60

10. Radiation Tissue Damage (Osteoradionecrosis) 10* - 60

11. Skin Grafts and Flaps (compromised) 6* - 40

12. Thermal Burns 5* - 45

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

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/K972908 · printed Nov 5, 2026

Cite this page

510(k) Report. “K972908: Sands Series Iii 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/K972908

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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