510(k) · Cleared
ClearedTerumo Gas Filter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terumo Cardiovascular Systems Corp. · CAH Filter, Bacterial, Breathing-Circuit
Cleared on Jun 10, 2002 as substantially equivalent to K832935 (Gish Biomedical, Inc., 1983) after a 73-day review. Its family tree reaches back 1 generation to 1983.
- Decided
- Jun 10, 2002
- Review
- 73 days
- Class
- Class II
- Product code
- CAH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K832935 (1983). No later device cites it as a predicate yet.
- Root · 1 generation backK832935 Gasline Filter, #EC-GLF SeriesGish Biomedical, Inc. · 1983
- This deviceK021020 Terumo Gas FilterTerumo Cardiovascular Systems Corp. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K832935 | Gasline Filter, #EC-GLF Series | Gish Biomedical, Inc. | 1983 | — |
| 0 (this device) | K021020 | Terumo Gas Filter | Terumo Cardiovascular Systems Corp. | 2002 | — |
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 CAH? 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 CAH device
- #1 K251583 Ambu® Virobac II® Exhalation Filterscore 11.6 · 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 |
|---|---|---|---|
| * | K832935 | Gasline Filter, #EC-GLF SeriesSummary page 1…fication is substantially equivalent to the predicate device, Gasline Filter (Gish Biomedical), which is legally marketed and was cleared by FDA on November 22,1983 (K832935L -\ fntended Use: The Terumo Gas Filter is i… | 1983 |
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.
- 1 other device also cites its predicate K832935.
How does its category compare?
All CAH devicesCAH Filter, Bacterial, Breathing-Circuit: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CAH
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CAH
237in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CAH
1in 2025
Class I (7 since 2007) Class II/III not classified
Adverse event reports per year · CAH
77in 2025
MAUDE reports naming product code CAH, 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 | — | 0 | 32 |
| 2008 | 1 | — | 0 | 27 |
| 2009 | 4 | 111 | 0 | 18 |
| 2010 | 5 | 216 | 2 | 40 |
| 2011 | 3 | 281 | 0 | 9 |
| 2012 | 3 | 212 | 0 | 16 |
| 2013 | 1 | — | 1 | 47 |
| 2014 | 4 | 250 | 1 | 98 |
| 2015 | 2 | — | 0 | 51 |
| 2016 | 0 | — | 0 | 34 |
| 2017 | 1 | — | 1 | 29 |
| 2018 | 0 | — | 0 | 33 |
| 2019 | 2 | — | 0 | 30 |
| 2020 | 2 | — | 0 | 33 |
| 2021 | 2 | — | 0 | 56 |
| 2022 | 3 | 204 | 6 (6) | 67 |
| 2023 | 3 | 237 | 0 | 40 |
| 2024 | 2 | — | 0 | 51 |
| 2025 | 0 | — | 1 (1) | 77 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Terumo Gas Filter is intended to remove particulate matter from the gases flowing
into the cardiopulmonary bypass circuit.
The Terumo Gas Filter is intended for use in procedures lasting up to 6-hours in duration.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021020 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021020: Terumo Gas Filter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021020
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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