510(k) · Cleared
ClearedPortable Oxygen Unit SCA900
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
San Cheong Co., Ltd. · CAN Regulator, Pressure, Gas Cylinder
Cleared on Apr 7, 2009 as substantially equivalent to K061785 (Responsive Respiratory, Inc., 2006) and 2 other predicates after a 432-day review. Its family tree reaches back 4 generations to 1996.
- Decided
- Apr 7, 2009
- Review
- 432 days
- Class
- Class I
- Product code
- CAN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K963247 (1996). 12 ancestors in all, the oldest K780359 (1978). No later device cites it as a predicate yet.
- Root · 4 generations backK963247 Victor Model Ocpr Oxygen Conserving Pressure RegulatorThermadyne Holings Corp. · 1996
- 3 generations backK992659 O2N Demand-II, Victor Model Ocpr-IIThermadyne Holings Corp. · 1999
- 2 generations backK031983 Inovo, Inc, Economizer Conserving RegulatorInovo, Inc. · 2003
- 1 generation backK061785 Cyl-Fil Oxygen SystemResponsive Respiratory, Inc. · 2006
- This deviceK080243 Portable Oxygen Unit SCA900San Cheong Co., Ltd. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K963247 | Victor Model Ocpr Oxygen Conserving Pressure Regulator | Thermadyne Holings Corp. | 1996 | — |
| −3 | K992659 | O2N Demand-II, Victor Model Ocpr-II | Thermadyne Holings Corp. | 1999 | — |
| −2 | K031983 | Inovo, Inc, Economizer Conserving Regulator | Inovo, Inc. | 2003 | — |
| −1 | K061785 | Cyl-Fil Oxygen System | Responsive Respiratory, Inc. | 2006 | — |
| 0 (this device) | K080243 | Portable Oxygen Unit SCA900 | San Cheong Co., Ltd. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1995 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 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 CAN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K061785 | Cyl-Fil Oxygen SystemSummary page 2…Sancheong Co., Ltd. Predicate Devices The subject device is substantially equivalent to the following predicate devices: * Cyl-Fil Oxygen System (K061785) manufactured by Responsive Respiratory Inc. * EZ-OX Plus (K053117) manufactured by Air Liquide Healthcare America. *… | 2006 |
| * | K053117 | EZ-OX PlusSummary page 2…is substantially equivalent to the following predicate devices: * Cyl-Fil Oxygen System (K061785) manufactured by Responsive Respiratory Inc. * EZ-OX Plus (K053117) manufactured by Air Liquide Healthcare America. * LIV (Linde Integrated Valve) (K063354) manufactured by Linde Gas Therape… | 2006 |
| * | K063354 | Linde Integrated Valve (Liv)Summary page 2…(K061785) manufactured by Responsive Respiratory Inc. * EZ-OX Plus (K053117) manufactured by Air Liquide Healthcare America. * LIV (Linde Integrated Valve) (K063354) manufactured by Linde Gas Therapeutics. Comparison to Predicate Devices Testing and other comparisons have established that… | 2007 |
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 13 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
- 2 of the 12 ancestors have a recall of any class.
How does its category compare?
All CAN devicesCAN Regulator, Pressure, Gas Cylinder: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · CAN
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · CAN
Too few CAN 510(k)s in any year since 2007 to give a median.
Recalls per year · CAN
3in 2021
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · CAN
3in 2025
MAUDE reports naming product code CAN, 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 | 0 | — | 0 | 2 |
| 2008 | 0 | — | 0 | 8 |
| 2009 | 1 | — | 5 | 5 |
| 2010 | 0 | — | 0 | 7 |
| 2011 | 0 | — | 0 | 5 |
| 2012 | 0 | — | 1 (1) | 23 |
| 2013 | 0 | — | 0 | 6 |
| 2014 | 0 | — | 0 | 12 |
| 2015 | 0 | — | 1 | 12 |
| 2016 | 0 | — | 0 | 13 |
| 2017 | 1 | — | 0 | 11 |
| 2018 | 0 | — | 0 | 238 |
| 2019 | 0 | — | 0 | 20 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 3 | 6 |
| 2022 | 0 | — | 0 | 6 |
| 2023 | 0 | — | 0 | 19 |
| 2024 | 0 | — | 0 | 59 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Portable Oxygen Unit SCA900 is an integrated portable oxygen delivery system intended to provide supplemental oxygen to adults; a pressure regulator, flow meter and oxygen cylinder fully integrated into single unit. For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx only. Compressed gas cylinders in service or in storage shall be stabilized or otherwise secured to prevent falling and'rolling.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080243 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080243: Portable Oxygen Unit SCA900.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080243
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