510(k) · Cleared
ClearedGas Filter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olson Medical Sales, Inc. · JOD Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass
Cleared on Mar 28, 2000 as substantially equivalent to K832935 (Gish Biomedical, Inc., 1983) after a 197-day review. Its family tree reaches back 1 generation to 1983.
- Decided
- Mar 28, 2000
- Review
- 197 days
- Class
- Class II
- Product code
- JOD
- 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 deviceK993060 Gas FilterOlson Medical Sales, Inc. · 2000
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) | K993060 | Gas Filter | Olson Medical Sales, Inc. | 2000 | — |
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 JOD? 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 |
|---|---|---|---|
| * | K832935 | Gasline Filter, #EC-GLF SeriesSummary page 1MAR 2 8 2000 O\C] 50 (90 Gas Filter 510(k) Submission: Component 0008-00313 Predicate Device: Gish Biomedical Gas Filter (K832935) Intended Use: The proposed gas filter and the Gish filter are intended to remove particulate matter from the gases flowing into… | 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 JOD devicesJOD Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JOD
FDA has decided no JOD device since 2007.
Median 510(k) review, days · JOD
Too few JOD 510(k)s in any year since 2007 to give a median.
Recalls per year · JOD
No recall names JOD since 2007.
Adverse event reports per year · JOD
1in 2015
MAUDE reports naming product code JOD, 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 | 3 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 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 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Gas Filter is intended to remove particulate matter from medical gases flowing into the cardiopulmonary bypass circuit for periods up to 6 hours.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K993060 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993060: Gas Filter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993060
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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