510(k) · Cleared
ClearedApogee
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Incoba Ltd D/B/A Dynaris · NFB Conserver, Oxygen
Cleared on Nov 14, 2020 as substantially equivalent to K090421 (Inspired Technologies, Inc., 2009) after a 270-day review. Its family tree reaches back 5 generations to 1994. 1 of the 11 devices in its family, counting itself, has a Class I recall.
- Decided
- Nov 14, 2020
- Review
- 270 days
- Class
- Class II
- Product code
- NFB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K933930 (1994). 10 ancestors in all, the oldest K800742 (1980). No later device cites it as a predicate yet. 1 of the 11 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK933930 Puritan-Bennett Companion 550 Liquid Oxygen Portable UnitPuritan Bennett Corp. · 1994
- 4 generations backK993220 Puritan-Bennett Helios Portable Liquid Oxygen SystemPuritan Bennett Corp. · 1999
- 3 generations backK013251 Spirit 300Caire, Inc. · 2001
- 2 generations backK072011 Copd Liquid Oxygen Portable, Model 300PCopd Partners, Inc. · 2007
- 1 generation backK090421 Model 350G Gas ConserverInspired Technologies, Inc. · 2009
- This deviceK200401 ApogeeIncoba Ltd D/B/A Dynaris · 2020
Class I recalls in this family
- K800742 Liberator/Stroller II System4 generations back · 1980
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K933930 | Puritan-Bennett Companion 550 Liquid Oxygen Portable Unit | Puritan Bennett Corp. | 1994 | — |
| −4 | K993220 | Puritan-Bennett Helios Portable Liquid Oxygen System | Puritan Bennett Corp. | 1999 | — |
| −3 | K013251 | Spirit 300 | Caire, Inc. | 2001 | — |
| −2 | K072011 | Copd Liquid Oxygen Portable, Model 300P | Copd Partners, Inc. | 2007 | — |
| −1 | K090421 | Model 350G Gas Conserver | Inspired Technologies, Inc. | 2009 | — |
| 0 (this device) | K200401 | Apogee | Incoba Ltd D/B/A Dynaris | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 1 |
| 1983 | 1 | 0 |
| 1996 | 1 | 0 |
| 2002 | 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.
1 device in this family has 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 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? (1)
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 |
|---|---|---|---|
| * | K090421 | Model 350G Gas ConserverSummary page 4…Oxygen Conserver (21 CFR 868.5905) Regulatory Class: II Product Code: NFB III Predicate Device: K090421 – Inspired Technologies Model 350G IV Device Description: The proposed device, Apogee, senses each nostril independently t… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 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.
- K800742Liberator/Stroller II SystemCryogenic Assoc. · 1980 · 4 generations back · ◆ in the 1980 ancestors bar of FIG. 14 Class I recalls
What does this lineage say?
- The line of descent spans 26 years and passes through 5 companies; a new generation was cleared every 5.6 years on median.
- 2 of the 10 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K090421.
How does its category compare?
All NFB devicesNFB Conserver, Oxygen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
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 Apogee is a gas conserver intended as a delivery device for medical grade oxygen from a high-pressure oxygen cylinders. Apogee is an ambulatory device which allows patients to ambulate longer than they would with continuous flow regulator on the same cylinder. The Apogee is intended to be used in the hospital, healthcare facilities, or home care environments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200401 · printed Nov 3, 2026
Cite this page
510(k) Report. “K200401: Apogee.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K200401
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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