510(k) · Cleared

Cleared

Coulter Immunoprep Leukocyte/Q-Prep Immuno WRK Sta

K874188510(k) TraditionalCleared Jan 19, 198897-day reviewClass I21 CFR 864.6160

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

Coulter Electronics, Inc. · GKM Hand-Tally, Differential

Cleared on Jan 19, 1988 after a 97-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided: Jan 19, 1988
Review: 97 days
Class: Class I
Product code: GKM
Recalls: None
Predicates: 0

1 later device descends from it, 1 citing it directly.

This deviceK874188 Coulter Immunoprep Leukocyte/Q-Prep Immuno WRK StaCoulter Electronics, Inc. · 1988
Descendant · cites it directly · 0 of its ownK130253 TQ-Prep Workstation, Prepplus 2 WorkstationBeckman Coulter, Inc. · 2013 · Recalled

Most influential descendants

Showing 1 of 1 · See all

K130253TQ-Prep Workstation, Prepplus 2 WorkstationBeckman Coulter, Inc. · 2013 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K874188	Coulter Immunoprep Leukocyte/Q-Prep Immuno WRK Sta	Coulter Electronics, Inc.	1988	—
+1	K130253	TQ-Prep Workstation, Prepplus 2 Workstation	Beckman Coulter, Inc.	2013	2

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	1	0

FIG. 1 — Lineage of K874188, 1988–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GKM? 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

Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

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
K130253	TQ-Prep Workstation, Prepplus 2 Workstation	Beckman Coulter, Inc.	2013	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?

Of its descendants, K130253 (Beckman Coulter, Inc., 2013) has gone furthest, with 0 descendants of its own.

How does its category compare?

All GKM devices

GKM Hand-Tally, Differential: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GKM

FDA has decided no GKM device since 2007.

Median 510(k) review, days · GKM

Too few GKM 510(k)s in any year since 2007 to give a median.

Recalls per year · GKM

No recall names GKM since 2007.

Adverse event reports per year · GKM

No MAUDE report names GKM since 2007.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

https://510kreport.com/device/K874188 · printed Nov 6, 2026

Cite this page

510(k) Report. “K874188: Coulter Immunoprep Leukocyte/Q-Prep Immuno WRK Sta.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K874188

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026