510(k) · Cleared
ClearedPrecision Liquid Oxygen System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Precision Medical, Inc. · BYJ Unit, Liquid-Oxygen, Portable
Cleared on Apr 21, 2011 as substantially equivalent to K041122 (Precision Medical, Inc., 2004) after a 160-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- Apr 21, 2011
- Review
- 160 days
- Class
- Class II
- Product code
- BYJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K933930 (1994). No later device cites it as a predicate yet.
- Root · 3 generations backK933930 Puritan-Bennett Companion 550 Liquid Oxygen Portable UnitPuritan Bennett Corp. · 1994
- 2 generations backK993220 Puritan-Bennett Helios Portable Liquid Oxygen SystemPuritan Bennett Corp. · 1999
- 1 generation backK041122 Precision Liquid Oxygen SystemPrecision Medical, Inc. · 2004 · Recalled
- This deviceK103324 Precision Liquid Oxygen SystemPrecision Medical, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K933930 | Puritan-Bennett Companion 550 Liquid Oxygen Portable Unit | Puritan Bennett Corp. | 1994 | — |
| −2 | K993220 | Puritan-Bennett Helios Portable Liquid Oxygen System | Puritan Bennett Corp. | 1999 | — |
| −1 | K041122 | Precision Liquid Oxygen System | Precision Medical, Inc. | 2004 | 1 |
| 0 (this device) | K103324 | Precision Liquid Oxygen System | Precision Medical, Inc. | 2011 | — |
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 BYJ? 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? (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 |
|---|---|---|---|
| * | K041122 | Precision Liquid Oxygen SystemSummary page 1…Class II Device Predicate Device Equivalence * Precision Medical, Inc, is claiming substantial equivalence to the Precision Medical 2200 liquid oxygen system K041 122 Intended Use The Precision Medical, Inc. Easy Mate 6+6 is intended to provide supplemental oxygen to patients who m… | 2004 |
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 17 years and passes through 2 companies; a new generation was cleared every 5.6 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 2 other devices also cite its predicate K041122.
How does its category compare?
All BYJ devicesBYJ Unit, Liquid-Oxygen, Portable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · BYJ
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · BYJ
164in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BYJ
4in 2022
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · BYJ
1in 2025
MAUDE reports naming product code BYJ, 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 | 2 | — | 1 | 24 |
| 2008 | 3 | 164 | 0 | 33 |
| 2009 | 0 | — | 0 | 12 |
| 2010 | 1 | — | 0 | 24 |
| 2011 | 1 | — | 0 | 15 |
| 2012 | 1 | — | 0 | 11 |
| 2013 | 1 | — | 0 | 22 |
| 2014 | 0 | — | 0 | 25 |
| 2015 | 0 | — | 0 | 34 |
| 2016 | 0 | — | 0 | 19 |
| 2017 | 0 | — | 0 | 18 |
| 2018 | 0 | — | 0 | 21 |
| 2019 | 0 | — | 0 | 24 |
| 2020 | 0 | — | 0 | 39 |
| 2021 | 0 | — | 0 | 7 |
| 2022 | 0 | — | 4 (4) | 4 |
| 2023 | 0 | — | 0 | 10 |
| 2024 | 0 | — | 0 | 10 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Precision Medical, Inc. Easy Mate 6 + 6 are intended to provide supplemental oxygen to patients who may have difficulty extracting oxygen from the air that they breathe. These patients would normally receive the oxygen via a nasal cannula. The systems delivers 100% oxygen at different flow settings. It is intended to be used as ambulatory source of oxygen both inside and out side of the patient's home.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103324 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103324: Precision Liquid Oxygen System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103324
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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