510(k) · Cleared
ClearedOrigio Gas Line Filter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Origio, Inc. · MQG Accessory, Assisted Reproduction
Cleared on May 7, 2014 as substantially equivalent to K001486 (<Genx> Intl., Inc., 2000) after a 236-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- May 7, 2014
- Review
- 236 days
- Class
- Class II
- Product code
- MQG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K001486 (2000). No later device cites it as a predicate yet.
- Root · 1 generation backK001486 Genx Coda Air Purification System<Genx> Intl., Inc. · 2000
- This deviceK132870 Origio Gas Line FilterOrigio, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001486 | Genx Coda Air Purification System | <Genx> Intl., Inc. | 2000 | — |
| 0 (this device) | K132870 | Origio Gas Line Filter | Origio, Inc. | 2014 | — |
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 MQG? 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 MQG device
- #1 K261083 Wallace® Aspiration Pump (WAPV1); Wallace®…score 12.2 · 2 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 |
|---|---|---|---|
| * | K001486 | Genx Coda Air Purification SystemSummary page 1…n Product Code: MOG Predicate Device Origio has compared the Origio Gas Line Filter to the CODA Inline Filter, which was included as part of 510(k) K001486 for the cgenX> CODA Air Purification System, submitted by <genX> International Company. Origio Gas Line Filter - Traditional… | 2000 |
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?
- Its one ancestor has no recall.
How does its category compare?
All MQG devicesMQG Accessory, Assisted Reproduction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · MQG
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MQG
135in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQG
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQG
1in 2025
MAUDE reports naming product code MQG, 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 | 4 | 137 | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 3 | 236 | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 1 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 3 | 135 | 0 | 0 |
| 2019 | 0 | — | 1 | 2 |
| 2020 | 0 | — | 1 | 3 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 1 | 3 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 1 | — | 0 | 1 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The ORIGIO@ Gas Line Filter is intended for the reduction of volatile organic compounds (VOC's) and particulate contaminants from supply gas lines to incubators and work stations that are used in assisted reproduction technologies and/or In vitro fertilization procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132870 · printed Nov 5, 2026
Cite this page
510(k) Report. “K132870: Origio Gas Line Filter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K132870
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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