510(k) · Cleared
Cleared6203
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Contemporary Products, Inc. · NFB Conserver, Oxygen
Cleared on Feb 13, 2003 as substantially equivalent to K992935 (Contemporary Products, Inc., 2000) and 2 other predicates after a 169-day review. Its family tree reaches back 3 generations to 1985.
- Decided
- Feb 13, 2003
- Review
- 169 days
- Class
- Class II
- Product code
- NFB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K852650 (1985). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK852650 Oxymatictm Electronic Oxgyen ConserverChad Therapeutics, Inc. · 1985
- 2 generations backK983601 Demand Oxygen Conserving Device, Docd, the DocMedical Electronic Devices, Inc. · 1998
- 1 generation backK992935 OCD2001Contemporary Products, Inc. · 2000
- This deviceK022865 6203Contemporary Products, Inc. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K852650 | Oxymatictm Electronic Oxgyen Conserver | Chad Therapeutics, Inc. | 1985 | — |
| −2 | K983601 | Demand Oxygen Conserving Device, Docd, the Doc | Medical Electronic Devices, Inc. | 1998 | — |
| −1 | K992935 | OCD2001 | Contemporary Products, Inc. | 2000 | — |
| 0 (this device) | K022865 | 6203 | Contemporary Products, Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K992935 | OCD2001Summary page 1…21CFR 868.5905 Product Code: 73 NFB Predicate Device Contemporary Products, Inc., OCD200 1 (K992935) Intended Use The 6203 is indicated for use to conserve oxygen for patients prescribed 1 to 6 liter… | 2000 |
| * | K953852 | Model Ipd Oxygen Conserving DeviceSummary page 3…evices including our own device, the OCD200 1 referenced above (K992935 now marketed as the 6200); the Invacare IPD Oxygen Conserving Device (K953852) and the Chad Therapeutics Oxymatic Electronic Oxygen Conserver (K852650). These predicate devices, like the… | 1995 |
| * | K852650 | Oxymatictm Electronic Oxgyen ConserverSummary page 3…ow marketed as the 6200); the Invacare IPD Oxygen Conserving Device (K953852) and the Chad Therapeutics Oxymatic Electronic Oxygen Conserver (K852650). These predicate devices, like the 6203, are electronic products that use a breath sensor and normally closed… | 1985 |
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?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
- None of the 4 ancestors has a recall.
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 Wave Conserver Model 6203 is indicated for use to conserve oxygen for patients prescribed 1 to 6 liters per minute of supplemental oxygen and use of a nasal cannula and USP bottled oxygen.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022865 · printed Nov 5, 2026
Cite this page
510(k) Report. “K022865: 6203.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K022865
Report an extraction error
Are you the manufacturer?
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