510(k) · Cleared
ClearedEZ-Assist-Fill
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Assist Fill, LLC · PCM Portable Liquid Oxygen Unit Stand
Cleared on Dec 27, 2012 as substantially equivalent to K993220 (Puritan Bennett Corp., 1999) and 1 other predicate after a 205-day review. Its family tree reaches back 2 generations to 1994.
- Decided
- Dec 27, 2012
- Review
- 205 days
- Class
- Class I
- Product code
- PCM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K933930 (1994). 3 ancestors in all, the oldest K813631 (1982). No later device cites it as a predicate yet.
View 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) | K121661 | EZ-Assist-Fill | Assist Fill, LLC | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 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 PCM? 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? (2)
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…vity Assist Device Classification: 21 CFR 890.5050 product code: PCM 4. Predicate Device Information: Puritan-Bennett Helios Universal, cleared under K993220 Fred Sammons Inc. Jar Holder & Opener cleared under K8 13631 5. Device Description: EZ-ASSIST-FILL is designe… | 1999 |
| * | K813631 | Jar Holder & OpenerSummary page 1…ode: PCM 4. Predicate Device Information: Puritan-Bennett Helios Universal, cleared under K993220 Fred Sammons Inc. Jar Holder & Opener cleared under K8 13631 5. Device Description: EZ-ASSIST-FILL is designed to support any combination of portable and reservoir units… | 1982 |
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 18 years and passes through 2 companies; a new generation was cleared every 13.2 years on median.
- None of the 3 ancestors has a recall.
- 3 other devices also cite its predicate K993220.
How does its category compare?
All PCM devicesPCM Portable Liquid Oxygen Unit Stand: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · PCM
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · PCM
Too few PCM 510(k)s in any year since 2007 to give a median.
Recalls per year · PCM
No recall names PCM since 2007.
Adverse event reports per year · PCM
1in 2024
MAUDE reports naming product code PCM, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
EZ-ASSIST-FILL is intended to assist the user with refilling the portable liquid oxygen tank. The device is for use in homes or clinics.
The EZ-ASSIST-FILL is neither a life-sustaining, nor life-supporting device. The device is intended for Over-the-Counter use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121661 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121661: EZ-Assist-Fill.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121661
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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