510(k) · Cleared

Cleared

Gish Arterial Filter with GBS Coating

K023833510(k) TraditionalCleared Mar 31, 2003133-day reviewClass II21 CFR 870.4260

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Gish Biomedical, Inc. · DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line

Cleared on Mar 31, 2003 as substantially equivalent to K914791 (Gish Biomedical, Inc., 1993) after a 133-day review. Its family tree reaches back 1 generation to 1993. 1 later device descends from it.

Decided: Mar 31, 2003
Review: 133 days
Class: Class II
Product code: DTM
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K914791 (1993). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK914791 Gish Arterial FilterGish Biomedical, Inc. · 1993
This deviceK023833 Gish Arterial Filter with GBS CoatingGish Biomedical, Inc. · 2003
Descendant · cites it directly · 0 of its ownK081054 Gish Arterial Filter with HA CoatingGish Biomedical, Inc. · 2009

Most influential descendants

Showing 1 of 1 · See all

K081054Gish Arterial Filter with HA CoatingGish Biomedical, Inc. · 2009 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K914791	Gish Arterial Filter	Gish Biomedical, Inc.	1993	—
0 (this device)	K023833	Gish Arterial Filter with GBS Coating	Gish Biomedical, Inc.	2003	—
+1	K081054	Gish Arterial Filter with HA Coating	Gish Biomedical, Inc.	2009	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0

FIG. 1 — Lineage of K023833, 1993–2009Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 DTM? 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 DTM device

#1 K251744 Affinity Pixie™ Arterial Filter with Balance™…score 11.0 · 2 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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	Applicant	Decided	Recalls
*	K914791	Gish Arterial Filter Summary page 1 …l Filter Classification Name: Arterial Line Blood Filter, Cardiopulmonary Bypass 3. Gish Arterial Filter, Gish Biomedical, Inc., K914791 4. Classifications Names & Citations: 21 CFR 870.4260, Arterial Line Blood Filter, Cardiopulmonary Bypass, Cl…	Gish Biomedical, Inc.	1993	—

Also cleared against K914791: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K081054	Gish Arterial Filter with HA Coating	Gish Biomedical, Inc.	2009	0

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.
Of its descendants, K081054 (Gish Biomedical, Inc., 2009) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K914791.

How does its category compare?

All DTM devices

DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DTM

2in 2024

2007high 5 (2009) · low 0 (2014)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DTM

246in 2009

2007high 246 (2009) · low 60 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DTM

1in 2019

2007high 1 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DTM

4in 2024

2007high 64 (2014) · low 0 (2009)2025

MAUDE reports naming product code DTM, 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	3	60	0	8
2008	1	—	1	2
2009	5	246	0	0
2010	2	—	0	3
2011	1	—	0	8
2012	2	—	0	6
2013	1	—	0	9
2014	0	—	0	64
2015	0	—	0	34
2016	0	—	0	27
2017	0	—	0	15
2018	0	—	0	23
2019	0	—	1	5
2020	0	—	0	1
2021	0	—	0	1
2022	0	—	0	4
2023	1	—	0	0
2024	2	—	0	4
2025	0	—	0	0
2026	1	—	0	—

What is it indicated for?

The GlSH arterial filters are indicated for use in the extracorporeal bypass circuit for the removal of microemboli. It is designed to operate at flow rates of one (1 .O) to six (6.0) liters per minute for periods up to six (6.0) hours.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K023833 · printed Nov 5, 2026

Cite this page

510(k) Report. “K023833: Gish Arterial Filter with GBS Coating.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K023833

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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