510(k) · Cleared
Recalled · 2007Oxy-Serve II Oxygen Conserving Regulator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Superior Products, Inc. · NFB Conserver, Oxygen
Cleared on Sep 21, 2005 as substantially equivalent to K010747 (Western Ent., 2001) after a 61-day review. Its family tree reaches back 1 generation to 2001. It has been recalled once.
- Decided
- Sep 21, 2005
- Review
- 61 days
- Class
- Class II
- Product code
- NFB
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K010747 (2001). No later device cites it as a predicate yet.
- Root · 1 generation backK010747 Opc Oxygen Conserving Regulator, Model Ahg 1968, Lin-7005, MDL-7609…Western Ent. · 2001 · Recalled
- This deviceK051988 Oxy-Serve II Oxygen Conserving RegulatorSuperior Products, Inc. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K010747 | Opc Oxygen Conserving Regulator, Model Ahg 1968, Lin-7005, MDL-7609, Mem-7612… | Western Ent. | 2001 | 3 |
| 0 (this device) | K051988 | Oxy-Serve II Oxygen Conserving Regulator | Superior Products, Inc. | 2005 | — |
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? (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 |
|---|---|---|---|
| * | K010747 | Opc Oxygen Conserving Regulator, Model Ahg 1968, Lin-7005, MDL-7609, Mem-7612, Opc-830Summary page 1…n-continuous ventilator (IPPB), 21 CFR 868.5905 Regulatory Class: II (two) Product Code: NFB 4. Predicate Device Information: 1. K010747 - OPC Oxygen Conserving Regulator - Western Medica, Corp. 5. Device Description: The Oxy-Serve II Oxygen Conserving Regu… | 2001 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 19, 2007 | Not classified | Z-0529-2008 | Component design/selection | Leakage: Device was leaking oxygen |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- 2 other devices also cite its predicate K010747.
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 Oxy-Serve Ii Oxygen Conserving Regulator is intended as an oxygen conservinga pressure regulator for ambulatory patients. The Conserving Regulator delivers the prescribed flow of oxygen only during the inhalation cycle, conserving oxygen during the exhalation cycle.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051988 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051988: Oxy-Serve II Oxygen Conserving Regulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051988
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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