510(k) Report

510(k) · Cleared

Cleared

Oxymatictm Electronic Oxgyen Conserver

K852650510(k) TraditionalCleared Aug 13, 198553-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 Aug 13, 1985 after a 53-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 of the 51 devices in its family, counting itself, have a Class I recall. 50 later devices descend from it.

Decided
Aug 13, 1985
Review
53 days
Class
Class II
Product code
NFB
Recalls
None
Predicates
0

50 later devices descend from it, 5 citing it directly. 4 of the 51 devices in this family, counting this one, have a Class I recall.

Descendants, by year cleared 1998: 2 descendants cleared1996: 1 descendant cleared2000: 1 descendant cleared2003: 2 descendants cleared2002: 2 descendants cleared1997: 1 descendant cleared2018: 4 descendants cleared2004: 2 descendants cleared2014: 3 descendants cleared2009: 1 descendant cleared2008: 2 descendants cleared2012: 1 descendant cleared2010: 3 descendants cleared, 1 with a Class I recall12017: 3 descendants cleared, 1 with a Class I recall12025: 7 descendants cleared2006: 3 descendants cleared2005: 2 descendants cleared2015: 2 descendants cleared2023: 2 descendants cleared2019: 2 descendants cleared, 1 with a Class I recall12021: 1 descendant cleared, 1 with a Class I recall12024: 3 descendants cleared1990200020102020
  1. This deviceK852650 Oxymatictm Electronic Oxgyen ConserverChad Therapeutics, Inc. · 1985
  2. Descendant · cites it directly · 42 of its ownK963042 Innosan Travelair S Portable Oxygen Concentrator, Code NO. M407001853Sim Italia S.R.L. · 1996
  3. Descendant · 2 generations on · 38 of its ownK013931 Omni Oxygen System, Model 1000Sequal Technologies, Inc. · 2002 · Recalled
  4. Descendant · 3 generations on · 18 of its ownK083163 Omni 2 Oxygen SystemSequal Technologies, Inc. · 2009 · Recalled
  5. Descendant · 3 generations on · 9 of its ownK120785 Omni 3 Oxygen SystemCaire, Inc. · 2012
  6. Descendant · 3 generations on · 7 of its ownK093261 MOVESThornhill Research, Inc. · 2010 · Recalled (Class I)

Showing 5 of 50 descendants. See all descendants

Descendants cleared per year

1996: 11997: 11998: 22000: 12002: 22003: 22004: 22005: 22006: 32008: 22009: 12010: 32012: 12014: 32015: 22017: 32018: 42019: 22021: 12023: 22024: 32025: 7
1996high 7 (2025) · low 0 (1999)2026

Class I recalls in this family

Most influential descendants

Showing 5 of 50 · See all
  • K963042Innosan Travelair S Portable Oxygen Concentrator, Code NO. M407001853Sim Italia S.R.L. · 1996 · cites it directly42descendants
  • K013931Omni Oxygen System, Model 1000Sequal Technologies, Inc. · 2002 · 2 generations on38descendants
  • K083163Omni 2 Oxygen SystemSequal Technologies, Inc. · 2009 · 3 generations on18descendants
  • K120785Omni 3 Oxygen SystemCaire, Inc. · 2012 · 3 generations on9descendants
  • K093261MOVESThornhill Research, Inc. · 2010 · 3 generations on7descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K852650Oxymatictm Electronic Oxgyen ConserverChad Therapeutics, Inc.1985—
+1K963042Innosan Travelair S Portable Oxygen Concentrator, Code NO. M407001853Sim Italia S.R.L.1996—
+2K013931Omni Oxygen System, Model 1000Sequal Technologies, Inc.20021
+3K083163Omni 2 Oxygen SystemSequal Technologies, Inc.20091
+3K120785Omni 3 Oxygen SystemCaire, Inc.2012—
+3K093261MOVESThornhill Research, Inc.2010Class I

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199710
199820
200010
200220
200320
200420
200520
200630
200820
200910
201031
201210
201430
201520
201731
201840
201921
202111
202320
202430
202570
FIG. 1 — Lineage of K852650, 1985–2025Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

4 devices in this family have a Class I recall. 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (50)

See all 50

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

NumberDeviceApplicantDecidedDescendants
K963042Innosan Travelair S Portable Oxygen Concentrator, Code NO. M407001853Sim Italia S.R.L.199642
K983459Pulsed Oxygen Conserving Device, PocdMedical Electronic Devices, Inc.19983
K983601Demand Oxygen Conserving Device, Docd, the DocMedical Electronic Devices, Inc.19982
K992935OCD2001Contemporary Products, Inc.20001
K0228656203Contemporary Products, Inc.20030

Has anything in its family been recalled? (4 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K093261MOVESThornhill Research, Inc. · 2010 · 3 generations on · ◆ in the 2010 descendants bar of FIG. 12 Class I recalls
  • K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc. · 2017 · 4 generations on · ◆ in the 2017 descendants bar of FIG. 114 Class I recalls
  • K181166Trilogy EvoRespironics, Inc. · 2019 · 5 generations on · ◆ in the 2019 descendants bar of FIG. 131 Class I recalls
  • K193586Vivo 45 LSBreas Medical AB · 2021 · 6 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K963042 (Sim Italia S.R.L., 1996) has gone furthest, with 42 descendants of its own.

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—
Cite this page

510(k) Report. “K852650: Oxymatictm Electronic Oxgyen Conserver.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K852650

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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