510(k) Report

510(k) · Cleared

Cleared

Chad Therapeutics Oxypenumatic Cypress Model 511

K020475510(k) TraditionalCleared Jul 5, 2002143-day reviewClass II21 CFR 868.5905

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Chad Therapeutics, Inc. · NFB Conserver, Oxygen

Cleared on Jul 5, 2002 as substantially equivalent to K992659 (Thermadyne Holings Corp., 1999) and 2 other predicates after a 143-day review. Its family tree reaches back 2 generations to 1996. 3 later devices descend from it.

Decided
Jul 5, 2002
Review
143 days
Class
Class II
Product code
NFB
Recalls
None
Predicates
3

Its longest line of descent runs back 2 generations to K963247 (1996). 4 ancestors in all. 3 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 2 other ancestors2006: 1 descendant cleared2007: 1 descendant cleared2025: 1 descendant clearedK963247 · Victor Model Ocpr Oxygen Conserving Pressure Regulator · Thermadyne Holings Corp. · 1996K992659 · O2N Demand-II, Victor Model Ocpr-II · Thermadyne Holings Corp. · 19991995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 2 descendants2 generations forward: 1 descendant K992659 · O2N Demand-II, Victor Model Ocpr-II · Thermadyne Holings Corp. · 1999K963247 · Victor Model Ocpr Oxygen Conserving Pressure Regulator · Thermadyne Holings Corp. · 19960
  1. Root · 2 generations backK963247 Victor Model Ocpr Oxygen Conserving Pressure RegulatorThermadyne Holings Corp. · 1996
  2. 1 generation backK992659 O2N Demand-II, Victor Model Ocpr-IIThermadyne Holings Corp. · 1999
  3. This deviceK020475 Chad Therapeutics Oxypenumatic Cypress Model 511Chad Therapeutics, Inc. · 2002
  4. Descendant · cites it directly · 1 of its ownK070740 Chad Therapeutics Bonsai Model 800Chad Therapeutics, Inc. · 2007
  5. Descendant · 2 generations on · 0 of its ownK250322 Respond OC Conserving Regulator (130-0800)Responsive Respiratory · 2025
  6. Descendant · cites it directly · 0 of its ownK060751 Inovo, Inc. Accupulse Single Lumen Conserving RegulatorInovo, Inc. · 2006 · Recalled

Most influential descendants

Showing 3 of 3 · See all
  • K070740Chad Therapeutics Bonsai Model 800Chad Therapeutics, Inc. · 2007 · cites it directly1descendant
  • K250322Respond OC Conserving Regulator (130-0800)Responsive Respiratory · 2025 · 2 generations on0descendants
  • K060751Inovo, Inc. Accupulse Single Lumen Conserving RegulatorInovo, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K963247Victor Model Ocpr Oxygen Conserving Pressure RegulatorThermadyne Holings Corp.1996—
−1K992659O2N Demand-II, Victor Model Ocpr-IIThermadyne Holings Corp.1999—
0 (this device)K020475Chad Therapeutics Oxypenumatic Cypress Model 511Chad Therapeutics, Inc.2002—
+1K070740Chad Therapeutics Bonsai Model 800Chad Therapeutics, Inc.2007—
+2K250322Respond OC Conserving Regulator (130-0800)Responsive Respiratory2025—
+1K060751Inovo, Inc. Accupulse Single Lumen Conserving RegulatorInovo, Inc.20061

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200120

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200710
202510
FIG. 1 — Lineage of K020475, 1996–2025Source: 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 NFB? 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 NFB device

  1. #1 K250322 Respond OC Conserving Regulator (130-0800)score 10.6 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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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
*K992659O2N Demand-II, Victor Model Ocpr-II
Summary page 1
…redicate Device Equivalence: Substantial equivalence is claimed to the Victor Medical Products 02n Demand II cleared for commercial distribution per K992659, the Western Medica OPC Oxygen Conserving Device cleared for commercial distribution per KO10747 and the Precision…
Thermadyne Holings Corp.1999—
*K010747Opc Oxygen Conserving Regulator, Model Ahg 1968, Lin-7005, MDL-7609, Mem-7612, Opc-830Western Ent.20013
*K001412PM 1800 Conserving DevicePrecision Medical, Inc.2001—

Also cleared against K992659: 1 other device →

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K070740Chad Therapeutics Bonsai Model 800Chad Therapeutics, Inc.20071
K060751Inovo, Inc. Accupulse Single Lumen Conserving RegulatorInovo, 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 6 years and passes through 2 companies; a new generation was cleared every 2.8 years on median.
  • 1 of the 4 ancestors has a recall of any class.
  • Of its descendants, K070740 (Chad Therapeutics, Inc., 2007) has gone furthest, with 1 descendant of its own.
  • 1 other device also cites its predicate K992659.

How does its category compare?

All NFB devices

NFB Conserver, Oxygen: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NFB

1in 2025

2007: 12009: 12010: 12011: 12013: 12016: 12020: 12022: 22025: 1
2007high 2 (2022) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NFB

Too few NFB 510(k)s in any year since 2007 to give a median.

Recalls per year · NFB

3in 2007

2007: 3
2007high 3 (2007) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NFB

8in 2025

2007: 32011: 12012: 32013: 52014: 22015: 42017: 92020: 32021: 22022: 12023: 42024: 12025: 8
2007high 9 (2017) · low 0 (2008)2025

MAUDE reports naming product code NFB, 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
20071—33
20080—00
20091—00
20101—00
20111—01
20120—03
20131—05
20140—02
20150—04
20161—00
20170—09
20180—00
20190—00
20201—03
20210—02
20222—01
20230—04
20240—01
20251—08
20260—0—

What is it indicated for?

The Chad Therapeutics OXYPNEUMATIC CYPRESS Model 511 is intended for

prescription use only, to be used as part of a portable oxygen delivery system for

patients that require supplemental oxygen in their home and for ambulatory use.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K020475: Chad Therapeutics Oxypenumatic Cypress Model 511.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020475

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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