510(k) · Cleared
ClearedPLIX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Respironics, Inc. · BYJ Unit, Liquid-Oxygen, Portable
Cleared on Apr 11, 2005 as substantially equivalent to K993220 (Puritan Bennett Corp., 1999) after a 52-day review. Its family tree reaches back 2 generations to 1994. 2 later devices descend from it.
- Decided
- Apr 11, 2005
- Review
- 52 days
- Class
- Class II
- Product code
- BYJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K933930 (1994). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK933930 Puritan-Bennett Companion 550 Liquid Oxygen Portable UnitPuritan Bennett Corp. · 1994
- 1 generation backK993220 Puritan-Bennett Helios Portable Liquid Oxygen SystemPuritan Bennett Corp. · 1999
- This deviceK050414 PLIXRespironics, Inc. · 2005
- Descendant · cites it directly · 1 of its ownK072723 Respironics GoloxRespironics, Inc. · 2008
- Descendant · 2 generations on · 0 of its ownK081779 GOLOX-93Respironics, Inc. · 2008
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K933930 | Puritan-Bennett Companion 550 Liquid Oxygen Portable Unit | Puritan Bennett Corp. | 1994 | — |
| −1 | K993220 | Puritan-Bennett Helios Portable Liquid Oxygen System | Puritan Bennett Corp. | 1999 | — |
| 0 (this device) | K050414 | PLIX | Respironics, Inc. | 2005 | — |
| +1 | K072723 | Respironics Golox | Respironics, Inc. | 2008 | — |
| +2 | K081779 | GOLOX-93 | Respironics, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 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 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 |
|---|---|---|---|
| * | K993220 | Puritan-Bennett Helios Portable Liquid Oxygen SystemSummary page 1…e liquid oxygen unit. (BYJ). Predicate Devices Puritan-Bennett Helios Portable Liquid Oxygen System (K993220) Device Description The PLOX is a double walled vacuum insulated cryogenic vessel designed to hold approximately 1 pound of… | 1999 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072723 | Respironics Golox | 2008 | 1 |
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 11 years and passes through 2 companies; a new generation was cleared every 5.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K072723 (Respironics, Inc., 2008) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K993220.
How does its category compare?
All BYJ devicesBYJ Unit, Liquid-Oxygen, Portable: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 PLOX is intended to provide supplemental oxygen to patients who have difficulty extracting oxygen from the air that they breathe. The patients would normally receive oxygen via a nasal cannula. It is intended for ambulatory use inside and outside of the home. It is not intended to be life supporting or life sustaining. The device has no contraindications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050414 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050414: PLIX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050414
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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