510(k) · Cleared
ClearedDemand Oxygen Conserving Device, Docd, the Doc
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Electronic Devices, Inc. · NFB Conserver, Oxygen
Cleared on Dec 15, 1998 as substantially equivalent to K953852 (Invacare Corp., 1995) and 1 other predicate after a 62-day review. Its family tree reaches back 1 generation to 1985. 2 later devices descend from it.
- Decided
- Dec 15, 1998
- Review
- 62 days
- Class
- Class II
- Product code
- NFB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K852650 (1985). 2 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK852650 Oxymatictm Electronic Oxgyen ConserverChad Therapeutics, Inc. · 1985
- This deviceK983601 Demand Oxygen Conserving Device, Docd, the DocMedical Electronic Devices, Inc. · 1998
- Descendant · cites it directly · 1 of its ownK992935 OCD2001Contemporary Products, Inc. · 2000
- Descendant · 2 generations on · 0 of its ownK022865 6203Contemporary Products, Inc. · 2003
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K852650 | Oxymatictm Electronic Oxgyen Conserver | Chad Therapeutics, Inc. | 1985 | — |
| 0 (this device) | K983601 | Demand Oxygen Conserving Device, Docd, the Doc | Medical Electronic Devices, Inc. | 1998 | — |
| +1 | K992935 | OCD2001 | Contemporary Products, Inc. | 2000 | — |
| +2 | K022865 | 6203 | Contemporary Products, Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
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 K250322 Respond OC Conserving Regulator (130-0800)score 10.6 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K953852 | Model Ipd Oxygen Conserving DeviceSummary page 1…Common name: Oxygen Conserver Classification name: Ventilator, Non-Continuous (Respirator) 21CFR 868.5905 Predicate Devices (1) Invacare IPD Oxygen Conserving Device (K953852) (2) CHAD Therapeutics, Inc. Oxymatic Electronic Oxygen Conserver (K852650) Intended Use The DOCD Demand Oxygen Conserving Devic… | 1995 |
| * | K852650 | Oxymatictm Electronic Oxgyen ConserverSummary page 1…ous (Respirator) 21CFR 868.5905 Predicate Devices (1) Invacare IPD Oxygen Conserving Device (K953852) (2) CHAD Therapeutics, Inc. Oxymatic Electronic Oxygen Conserver (K852650) Intended Use The DOCD Demand Oxygen Conserving Device is indicated for use to conserve oxygen for patients prescribed 0 to 6 l… | 1985 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K992935 | OCD2001 | 2000 | 1 |
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?
How does its category compare?
All NFB devicesNFB Conserver, Oxygen: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NFB
1in 2025
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
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NFB
8in 2025
MAUDE reports naming product code NFB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 3 | 3 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 1 | — | 0 | 5 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 4 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 9 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 2 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 1 | — | 0 | 8 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The DOC Demand Oxygen Conserving Device is indicated for use to conserve oxygen for patients prescribed 1 to 6 liters per minute of supplemental oxygen and use nasal cannulas and USP bottled oxygen.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K983601 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983601: Demand Oxygen Conserving Device, Docd, the Doc.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983601
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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